Trial Outcomes & Findings for A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People (NCT NCT05580003)
NCT ID: NCT05580003
Last Updated: 2024-11-21
Results Overview
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
COMPLETED
PHASE1
94 participants
From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)
2024-11-21
Participant Flow
A total of 94 participants were enrolled across Belgium and United States.
Participant milestones
| Measure |
P1: C1: Placebo,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg, Fast
In this cohort (C), participants received a single dose of placebo as an oral suspension in the fasted (fast) state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 milligram (mg) as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C1: PF-07817883 150mg,Fast/Placebo,Fast/PF-07817883 4000mg,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/Placebo,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C2: Placebo,Fast/PF-07817883 3000mg,Fast/Placebo,Fed
Participants received a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C2: PF-07817883 500mg,Fast/Placebo,Fast/PF-07817883 500mg,Fed
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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P1: C2: PF-07817883 500mg,Fast/PF-07817883 3000mg,Fast/PF-07817883 500mg,Fed
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
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Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
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Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
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Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
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Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
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Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
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Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
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Part 3: Treatment Sequence ABCD
Participants received treatments A, B, C and D in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 spray dried dispersion (SDD) 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 3: Treatment Sequence BCAD
Participants received treatments B, C, A and D in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 3: Treatment Sequence CABD
Participants received treatments C, A, B and D in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 3: Treatment Sequence BACE
Participants received treatments B, A, C and E in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 3: Treatment Sequence ACBE
Participants received treatments A, C, B and E in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 3: Treatment Sequence CBAE
Participants received treatments C, B, A and E in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
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Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
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Part 5: Treatment Sequence AB
Participants received a single dose of midazolam 5 mg orally on Day 1 of Period 1 followed by a 2-day washout period. In Period 2, participants received PF-07817883 BID orally for 10 days followed by single dose of midazolam 5 mg on Day 10 followed by a washout of at least 7 days.
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Part 5: Treatment Sequence BA
In Period 1, participants received PF-07817883 BID orally for 10 days and on Day 10, participants received a single oral dose of 5 mg midazolam administered with PF-07817883 followed by a washout of at least 7 days. In Period 2, participants received a single dose of midazolam 5 mg orally followed by a 2-day washout period.
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Part 6: Treatment Sequence ABC
Participants received treatment A, B and C in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
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Part 6: Treatment Sequence BCA
Participants received treatment B, C and A in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
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Part 6: Treatment Sequence CAB
Participants received treatment C, A and B in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
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Part 6: Treatment Sequence BAC
Participants received treatment B, A and C in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
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Part 6: Treatment Sequence ACB
Participants received treatment A, C and B in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
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Part 6: Treatment Sequence CBA
Participants received treatment C, B and A in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
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Part 5:SequenceAB:Washout1(Upto 2 Days)
COMPLETED
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Part (P) 1 Treatment Period 1 (Day 1)
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Part (P) 1 Treatment Period 1 (Day 1)
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Part (P) 1 Treatment Period 1 (Day 1)
NOT COMPLETED
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Part 1: Washout 1 (up to 5 Days)
STARTED
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Part 1: Washout 1 (up to 5 Days)
COMPLETED
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Part 1: Washout 1 (up to 5 Days)
NOT COMPLETED
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Part 1 Treatment Period 2 (Day 1)
STARTED
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Part 1 Treatment Period 2 (Day 1)
COMPLETED
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Part 1 Treatment Period 2 (Day 1)
NOT COMPLETED
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Part 1: Washout 2 (up to 5 Days)
STARTED
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Part 1: Washout 2 (up to 5 Days)
COMPLETED
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Part 1: Washout 2 (up to 5 Days)
NOT COMPLETED
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Part 1: Treatment Period 3 (Day 1)
STARTED
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Part 1: Treatment Period 3 (Day 1)
COMPLETED
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Part 1: Treatment Period 3 (Day 1)
NOT COMPLETED
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Part 2 (up to 10 Days)
STARTED
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Part 2 (up to 10 Days)
COMPLETED
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Part 2 (up to 10 Days)
NOT COMPLETED
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Part 3 Period 1 (Day 1)
STARTED
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Part 3 Period 1 (Day 1)
COMPLETED
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Part 3 Period 1 (Day 1)
NOT COMPLETED
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Part 3: Washout 1 (up to 3 Days)
STARTED
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Part 3: Washout 1 (up to 3 Days)
COMPLETED
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Part 3: Washout 1 (up to 3 Days)
NOT COMPLETED
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|
0
|
0
|
0
|
0
|
|
Part 3: Period 2 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 2 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
|
Part 3: Period 2 (Day 1)
NOT COMPLETED
|
0
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0
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0
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0
|
0
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0
|
0
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0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 2 (up to 3 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 2 (up to 3 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
|
0
|
0
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0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 2 (up to 3 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 3 (Day 1)
STARTED
|
0
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0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 3 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 3 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 3 (up to 3 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 3 (up to 3 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Washout 3 (up to 3 Days)
NOT COMPLETED
|
0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 4 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 4 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 3: Period 4 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4 (Day 1 to Day 11)
STARTED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4 (Day 1 to Day 11)
COMPLETED
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4 (Day 1 to Day 11)
NOT COMPLETED
|
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0
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0
|
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0
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0
|
0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence AB: Period 1 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence AB: Period 1 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence AB: Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5:SequenceAB:Washout1(Upto 2 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5:SequenceAB:Washout1(Upto 2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:SequenceAB:Period2(up to 10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:SequenceAB:Period2(up to 10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:SequenceAB:Period2(up to 10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence AB:Washout2(up to 7 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence AB:Washout2(up to 7 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence AB:Washout2(up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Period1(up to 10 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Period1(up to 10 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Period1(up to 10 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout1(up to 7 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout1(up to 7 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout1(up to 7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence BA: Period 2 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence BA: Period 2 (Day 1)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence BA: Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout2(up to 2 Days)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout2(up to 2 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Washout2(up to 2 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 6 Period 1 (Day 1)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Part 6 Period 1 (Day 1)
COMPLETED
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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4
|
4
|
4
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4
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4
|
4
|
|
Part 6 Period 1 (Day 1)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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|
Part 6: Washout 1 (up to 7 Days)
STARTED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Part 6: Washout 1 (up to 7 Days)
COMPLETED
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Part 6: Washout 1 (up to 7 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
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0
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0
|
0
|
|
Part 6 Period 2 (Day 1)
STARTED
|
0
|
0
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0
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0
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
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0
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4
|
4
|
4
|
4
|
4
|
4
|
|
Part 6 Period 2 (Day 1)
COMPLETED
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
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0
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0
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0
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0
|
0
|
4
|
4
|
3
|
4
|
4
|
3
|
|
Part 6 Period 2 (Day 1)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Part 6: Washout 2 (up to 7 Days)
STARTED
|
0
|
0
|
0
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0
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0
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0
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
4
|
4
|
3
|
4
|
4
|
3
|
|
Part 6: Washout 2 (up to 7 Days)
COMPLETED
|
0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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4
|
4
|
3
|
4
|
4
|
3
|
|
Part 6: Washout 2 (up to 7 Days)
NOT COMPLETED
|
0
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0
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0
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0
|
0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 6 Period 3 (Day 1)
STARTED
|
0
|
0
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0
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0
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0
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0
|
0
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0
|
0
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0
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0
|
0
|
0
|
0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
4
|
4
|
3
|
4
|
4
|
3
|
|
Part 6 Period 3 (Day 1)
COMPLETED
|
0
|
0
|
0
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0
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0
|
0
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0
|
0
|
0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
4
|
4
|
3
|
4
|
4
|
3
|
|
Part 6 Period 3 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
P1: C1: Placebo,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg, Fast
In this cohort (C), participants received a single dose of placebo as an oral suspension in the fasted (fast) state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 milligram (mg) as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150mg,Fast/Placebo,Fast/PF-07817883 4000mg,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/Placebo,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg,Fast
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: Placebo,Fast/PF-07817883 3000mg,Fast/Placebo,Fed
Participants received a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: PF-07817883 500mg,Fast/Placebo,Fast/PF-07817883 500mg,Fed
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: PF-07817883 500mg,Fast/PF-07817883 3000mg,Fast/PF-07817883 500mg,Fed
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
Part 2: Placebo (Suspension) BID, Fasted
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
|
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 3: Treatment Sequence ABCD
Participants received treatments A, B, C and D in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 spray dried dispersion (SDD) 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence BCAD
Participants received treatments B, C, A and D in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence CABD
Participants received treatments C, A, B and D in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence BACE
Participants received treatments B, A, C and E in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence ACBE
Participants received treatments A, C, B and E in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence CBAE
Participants received treatments C, B, A and E in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 4: PF-07817883 600 mg (Suspension), Fasted
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
|
Part 5: Treatment Sequence AB
Participants received a single dose of midazolam 5 mg orally on Day 1 of Period 1 followed by a 2-day washout period. In Period 2, participants received PF-07817883 BID orally for 10 days followed by single dose of midazolam 5 mg on Day 10 followed by a washout of at least 7 days.
|
Part 5: Treatment Sequence BA
In Period 1, participants received PF-07817883 BID orally for 10 days and on Day 10, participants received a single oral dose of 5 mg midazolam administered with PF-07817883 followed by a washout of at least 7 days. In Period 2, participants received a single dose of midazolam 5 mg orally followed by a 2-day washout period.
|
Part 6: Treatment Sequence ABC
Participants received treatment A, B and C in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence BCA
Participants received treatment B, C and A in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence CAB
Participants received treatment C, A and B in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence BAC
Participants received treatment B, A and C in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence ACB
Participants received treatment A, C and B in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence CBA
Participants received treatment C, B and A in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part (P) 1 Treatment Period 1 (Day 1)
Withdrawal by Subject
|
0
|
0
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0
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0
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0
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0
|
1
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
|
Part 1 Treatment Period 2 (Day 1)
Physician Decision
|
0
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0
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0
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0
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0
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
|
Part 1 Treatment Period 2 (Day 1)
Other
|
0
|
0
|
0
|
1
|
0
|
0
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0
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0
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0
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0
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0
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0
|
0
|
0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
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0
|
0
|
0
|
0
|
|
Part 1: Treatment Period 3 (Day 1)
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 2 (up to 10 Days)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 4 (Day 1 to Day 11)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 5: Sequence AB: Period 1 (Day 1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part5:Sequence BA:Period1(up to 10 Days)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part 6 Period 2 (Day 1)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Part 6 Period 2 (Day 1)
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Baseline characteristics by cohort
| Measure |
P1: C1: Placebo,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg, Fast
n=2 Participants
In this cohort (C), participants received a single dose of placebo as an oral suspension in the fasted (fast) state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 milligram (mg) as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150mg,Fast/Placebo,Fast/PF-07817883 4000mg,Fast
n=2 Participants
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/Placebo,Fast
n=2 Participants
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C1: PF-07817883 150 mg,Fast/PF-07817883 1500mg,Fast/PF-07817883 4000mg,Fast
n=2 Participants
Participants received a single dose of PF-07817883 150 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 1500 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 4000 mg as an oral suspension in the fasted state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: Placebo,Fast/PF-07817883 3000mg,Fast/Placebo,Fed
n=2 Participants
Participants received a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of placebo as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: PF-07817883 500mg,Fast/Placebo,Fast/PF-07817883 500mg,Fed
n=2 Participants
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of placebo as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
P1: C2: PF-07817883 500mg,Fast/PF-07817883 3000mg,Fast/PF-07817883 500mg,Fed
n=4 Participants
Participants received a single dose of PF-07817883 500 mg as an oral suspension in the fasted state on Day 1 of Period 1 followed by a single dose of PF-07817883 3000 mg as an oral suspension in the fasted state on Day 1 of Period 2. Participants were administered a single dose of PF-07817883 500 mg as an oral suspension in the fed state on Day 1 of Period 3. There was a washout of at least 5 days between two doses.
|
Part 2: Placebo (Suspension) BID, Fasted
n=6 Participants
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
n=4 Participants
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
n=4 Participants
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
n=4 Participants
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
|
Part 2: Placebo (Suspension) BID, Fasted, Chinese
n=1 Participants
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
n=3 Participants
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 3: Treatment Sequence ABCD
n=2 Participants
Participants received treatments A, B, C and D in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 spray dried dispersion (SDD) 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence BCAD
n=2 Participants
Participants received treatments B, C, A and D in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence CABD
n=2 Participants
Participants received treatments C, A, B and D in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment D: Single dose of PF-07817883 SDD 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence BACE
n=2 Participants
Participants received treatments B, A, C and E in Period 1, 2, 3 and 4 respectively. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence ACBE
n=2 Participants
Participants received treatments A, C, B and E in Period 1, 2, 3 and 4 respectively. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 3: Treatment Sequence CBAE
n=2 Participants
Participants received treatments C, B, A and E in Period 1, 2, 3 and 4 respectively. Treatment C: Single dose of PF-07817883 600 mg suspension in fasted conditions. Treatment B: Single dose of PF-07817883 crystalline 600 mg tablet in fasted conditions. Treatment A: Single dose of PF-07817883 SDD 600 mg tablets in fasted conditions. Treatment E: Single dose of PF-07817883 crystalline 600 mg tablet in fed conditions. There was a washout of at least 3 days between 2 doses.
|
Part 4: PF-07817883 600 mg (Suspension), Fasted
n=6 Participants
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
|
Part 5: Treatment Sequence AB
n=7 Participants
Participants received a single dose of midazolam 5 mg orally on Day 1 of Period 1 followed by a 2-day washout period. In Period 2, participants received PF-07817883 BID orally for 10 days followed by single dose of midazolam 5 mg on Day 10 followed by a washout of at least 7 days.
|
Part 5: Treatment Sequence BA
n=7 Participants
In Period 1, participants received PF-07817883 BID orally for 10 days and on Day 10, participants received a single oral dose of 5 mg midazolam administered with PF-07817883 followed by a washout of at least 7 days. In Period 2, participants received a single dose of midazolam 5 mg orally followed by a 2-day washout period.
|
Part 6: Treatment Sequence ABC
n=4 Participants
Participants received treatment A, B and C in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence BCA
n=4 Participants
Participants received treatment B, C and A in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence CAB
n=4 Participants
Participants received treatment C, A and B in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence BAC
n=4 Participants
Participants received treatment B, A and C in Period 1, 2 and 3 respectively. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence ACB
n=4 Participants
Participants received treatment A, C and B in Period 1, 2 and 3 respectively. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Each period was separated by a washout of at least 7 days.
|
Part 6: Treatment Sequence CBA
n=4 Participants
Participants received treatment C, B and A in Period 1, 2 and 3 respectively. Treatment C: Single dose of Moxifloxacin 400 mg oral tablet at 0 hour and placebo at 1 hour following an overnight fast of at least 10 hours. Treatment B: Single dose of Placebo oral suspension following an overnight fast of at least 10 hours. Treatment A: PF-07817883 6000 mg oral suspension administered as 2 split doses of 3000 mg at 0 and 1 hour under fasted conditions. Each period was separated by a washout of at least 7 days.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
18-44 Years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=11 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=408 Participants
|
64 Participants
n=206 Participants
|
|
Age, Customized
45-60 Years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
29 Participants
n=206 Participants
|
|
Age, Customized
Not Disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
19 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
6 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=408 Participants
|
74 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Not Disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
19 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=408 Participants
|
31 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
2 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=408 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
33 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
6 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
1 Participants
n=11 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=408 Participants
|
60 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=10 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=2 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory parameters included: (lymphocytes less than (\<) 0.8\*lower limit of normal \[LLN\] \[10\^3 per millimeter cube {mm3}\], lymphocytes/leukocytes \<0.8\*LLN \[percentage {%}\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], monocytes/leukocytes greater than (\>) 1.2\*upper limit of normal \[ULN\] \[%\], partial thromboplastin time \>1.1\*ULN \[seconds\]), chemistry (bicarbonate \<0.9\*LLN \[milliequivalents per liter {mEq/L}\], creatine kinase \>2.0\*ULN \[units per liter {U/L}\], lipase \>1.5\*ULN \[U/L\]), and urinalysis (urine hemoglobin greater than or equal to \[\>=\] 1, leukocyte esterase \>=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=10 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=2 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Laboratory Test Abnormalities
|
1 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Day 2 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\<) 90 millimeter of mercury (mmHg), change greater than or equal to (\>=) 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 beats per minute (bpm), value \> 120 bpm.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=10 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=2 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP Change >= 20 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP Change >= 20 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP value < 90 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP Change >= 30 mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP Change >= 30 mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP Value < 50 mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
PR Value < 40 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
PR Value > 120 bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 2 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=10 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=2 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=1 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory parameters included: hematology (lymphocytes/leukocytes \>1.2\*ULN \[%\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], monocytes/leukocytes \>1.2\*ULN \[%\]), chemistry (urate \>1.2\*ULN \[milligrams per deciliter\] {mg/dL}), and urinalysis (ketones \>=1, urine hemoglobin \>=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=1 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Laboratory Test Abnormalities
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 12Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=1 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 12Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=1 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of oral formulation and suspension were reported in statistical analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
AUCinf
|
—
|
42970 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
44140 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
28430 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
42930 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
46170 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
|
Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension
AUClast
|
—
|
42540 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
43570 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
27750 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
41620 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
35930 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of oral formulation and suspension were reported in statistical analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension
|
—
|
9354 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
6934 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
4590 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
6284 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
5008 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 144 hours post-dosePopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
The percentage of total dose administered recovered in urine was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Percentage of Total Dose Administered Recovered in Urine
|
—
|
12.6 Percentage dose excreted
Standard Deviation 4.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 144 hours post-dosePopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
The percentage of total dose administered recovered in feces was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Percentage of Total Dose Administered Recovered in Feces
|
—
|
88.9 Percentage dose excreted
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 144 hours post-dosePopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces
|
—
|
101.5 Percentage dose excreted
Standard Deviation 7.7
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Cmax of midazolam was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Maximum Observed Concentration (Cmax) of Midazolam
|
—
|
33.71 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
30.20 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
AUCinf of midazolam was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam
|
—
|
94.30 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
79.85 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=24 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Number of Participants With TEAEs
|
—
|
4 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 52 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Laboratory parameters included: hematology (lymphocytes \<0.6\*LLN \[10\^3/mm3\], lymphocytes/leukocytes \>1.2\*ULN \[%\], neutrophils \<0.8\*LLN \[10\^3/mm3\], neutrophils/leukocytes \<0.8\*LLN \[%\], basophils/leukocytes \>1.2\*ULN \[%\], eosinophils/leukocytes \>1.2\*ULN \[%\], monocytes/leukocytes \>1.2\*ULN \[%\], partial thromboplastin time \>1.1\*ULN \[seconds\], prothrombin time \>1.1\*ULN \[seconds\]), chemistry (bicarbonate \<0.9\*LLN \[mEq/L\], creatine kinase \> 2.0\*ULN \[U/L\], lipase \> 1.5\*ULN \[U/L\], urobilinogen \>=1 \[ehrlich units/deciliter\] {EU/dL}) and urinalysis (urine hemoglobin \>=1, leukocyte esterase \>=1, ketones \>=1, bacteria \>20 \[per low power field\] {/lpf}). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=22 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=24 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Number of Participants With Laboratory Test Abnormalities
|
—
|
12 Participants
|
12 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 6 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=24 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP value < 90 mmHg
|
—
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg increase
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg decrease
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP value < 50 mmHg
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg increase
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg decrease
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value < 40 bpm
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value > 120 bpm
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to Day 6 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured QTcF interval, aggregate 450 milliseconds (msec) \< value \<= 480 msec and QTcF interval, aggregate 30 msec \< change \<= 60 msec. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=24 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Number of Participants According to Categorization of ECG Data
QTCF interval, aggregate 450 msec < Value <= 480 msec
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Part 6: Number of Participants According to Categorization of ECG Data
QTCF interval, aggregate 30 msec < Change <= 60 msec
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Cmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum Observed Concentration (Cmax) of PF-07817883
|
34670 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
2269 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 51
|
6235 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
3223 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
17420 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 36
|
34420 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Tmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Time for Cmax (Tmax) of PF-07817883
|
1.00 Hours
Interval 0.55 to 1.5
|
1.00 Hours
Interval 0.5 to 1.5
|
0.792 Hours
Interval 0.5 to 1.5
|
1.25 Hours
Interval 1.0 to 2.0
|
0.500 Hours
Interval 0.5 to 1.0
|
0.500 Hours
Interval 0.5 to 1.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
|
185700 Nanogram*hour per milliliter
Geometric Coefficient of Variation 17
|
10890 Nanogram*hour per milliliter
Geometric Coefficient of Variation 47
|
34580 Nanogram*hour per milliliter
Geometric Coefficient of Variation 25
|
27080 Nanogram*hour per milliliter
Geometric Coefficient of Variation 25
|
83490 Nanogram*hour per milliliter
Geometric Coefficient of Variation 36
|
160700 Nanogram*hour per milliliter
Geometric Coefficient of Variation 33
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Normalized Cmax (Cmax[dn]) of PF-07817883
|
8.672 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 36
|
15.14 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 51
|
12.48 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 19
|
6.445 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 13
|
11.61 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 36
|
11.49 Nanogram per milliliter per milligram
Geometric Coefficient of Variation 12
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
AUClast(dn) of PF-07817883 was reported in this outcome measure. AUClast(dn) was calculated by AUClast/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Normalized AUClast (AUClast[dn]) of PF-07817883
|
46.43 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 17
|
72.61 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 47
|
69.17 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 25
|
54.16 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 25
|
55.64 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 35
|
53.53 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 33
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
|
189400 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 19
|
11250 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 53
|
35950 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 25
|
28120 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
85320 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
166100 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 34
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf(dn) of PF-07817883 was reported in this outcome measure. AUCinf(dn) was calculated as AUCinf/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Dose Normalized AUCinf (AUCinf[dn]) of PF-07817883
|
47.34 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 19
|
74.99 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 53
|
71.81 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 25
|
56.23 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 28
|
56.86 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 34
|
55.33 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 35
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Terminal Half-Life (t1/2) of PF-07817883
|
13.05 Hours
Standard Deviation 7.3974
|
4.534 Hours
Standard Deviation 0.50659
|
13.88 Hours
Standard Deviation 10.838
|
15.95 Hours
Standard Deviation 8.4657
|
10.84 Hours
Standard Deviation 6.1747
|
18.79 Hours
Standard Deviation 14.234
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf\*kel).
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Volume of Distribution (Vz/F) of PF-07817883
|
358.7 Liter (L)
Geometric Coefficient of Variation 44
|
86.87 Liter (L)
Geometric Coefficient of Variation 48
|
209.5 Liter (L)
Geometric Coefficient of Variation 101
|
366.1 Liter (L)
Geometric Coefficient of Variation 50
|
242.9 Liter (L)
Geometric Coefficient of Variation 80
|
367.4 Liter (L)
Geometric Coefficient of Variation 87
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 1: Apparent Clearance (CL/F) of PF-07817883
|
21.13 Liter per hour (L/hr)
Geometric Coefficient of Variation 19
|
13.33 Liter per hour (L/hr)
Geometric Coefficient of Variation 53
|
13.93 Liter per hour (L/hr)
Geometric Coefficient of Variation 25
|
17.79 Liter per hour (L/hr)
Geometric Coefficient of Variation 28
|
17.58 Liter per hour (L/hr)
Geometric Coefficient of Variation 35
|
18.09 Liter per hour (L/hr)
Geometric Coefficient of Variation 35
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Cmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
Day 1
|
—
|
3582 Nanogram/milliliter
Geometric Coefficient of Variation 20
|
8470 Nanogram/milliliter
Geometric Coefficient of Variation 39
|
24100 Nanogram/milliliter
Geometric Coefficient of Variation 22
|
8381 Nanogram/milliliter
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
Day 5
|
—
|
4234 Nanogram/milliliter
Geometric Coefficient of Variation 7
|
9112 Nanogram/milliliter
Geometric Coefficient of Variation 14
|
27530 Nanogram/milliliter
Geometric Coefficient of Variation 22
|
8260 Nanogram/milliliter
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
|
Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10
Day 10
|
—
|
3492 Nanogram/milliliter
Geometric Coefficient of Variation 15
|
7852 Nanogram/milliliter
Geometric Coefficient of Variation 21
|
23420 Nanogram/milliliter
Geometric Coefficient of Variation 14
|
7306 Nanogram/milliliter
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Tmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
Day 1
|
—
|
0.759 Hours
Interval 0.5 to 1.0
|
0.775 Hours
Interval 0.5 to 1.0
|
0.500 Hours
Interval 0.5 to 1.5
|
1.00 Hours
Interval 1.0 to 1.05
|
—
|
—
|
—
|
|
Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
Day 10
|
—
|
0.500 Hours
Interval 0.5 to 1.0
|
0.500 Hours
Interval 0.5 to 1.0
|
0.500 Hours
Interval 0.5 to 0.5
|
0.533 Hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
|
Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10
Day 5
|
—
|
0.859 Hours
Interval 0.5 to 1.02
|
0.500 Hours
Interval 0.5 to 0.5
|
0.500 Hours
Interval 0.5 to 1.0
|
0.500 Hours
Interval 0.5 to 1.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
AUCtau was defined as area under the plasma concentration-time profile from time 0 to time tau, the dosing interval, where tau= 12 hours. AUCtau of PF-07817883 was reported in this outcome measure. AUCtau was calculated by linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
Day 1
|
—
|
14760 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
36440 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
108400 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15
|
36880 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
|
Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
Day 5
|
—
|
18460 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 15
|
36300 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 10
|
114000 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
37680 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
|
Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10
Day 10
|
—
|
17180 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 10
|
34960 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 8
|
103900 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 18
|
34650 Nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 hours on Day 5 and Day 10Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
C12 of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
389.3 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
734.5 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
2598 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
716.0 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
|
Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
425.7 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
865.9 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
2315 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
585.5 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Cmax(dn) of PF-07817883 was reported in this outcome measure. Cmax(dn) was calculated as Cmax/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
Day 1
|
—
|
17.93 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 20
|
14.15 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 39
|
16.07 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 22
|
14.00 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
|
Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
Day 5
|
—
|
21.18 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 7
|
15.20 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 13
|
18.35 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 22
|
13.76 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
|
Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10
Day 10
|
—
|
17.47 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 15
|
13.07 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 21
|
15.61 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 14
|
12.20 Nanogram/milliliter/milligram (ng/mL/mg)
Geometric Coefficient of Variation 25
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 and Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
AUCtau(dn) was defined as dose normalized AUCtau, where tau= 12 hours. AUCtau(dn) of PF-07817883 was reported in this outcome measure. AUCtau(dn) was calculated as AUCtau/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
Day 1
|
—
|
73.94 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 26
|
60.70 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 27
|
72.25 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 15
|
61.44 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
|
Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
Day 5
|
—
|
92.46 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 15
|
60.49 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 10
|
76.20 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 23
|
62.82 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
|
Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10
Day 10
|
—
|
86.04 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 10
|
58.28 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 8
|
69.43 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 18
|
57.78 Nanogram*hour/milliliter/milligram
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Cav of PF-07817883 was reported in this outcome measure. Cav was calculated as AUCtau/12.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
1542 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
3022 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 10
|
9515 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
3140 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
|
Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
1434 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 10
|
2914 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 8
|
8672 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
2890 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Rac was defined as observed accumulation ratio for AUCtau, where tau= 12 hours. Rac of PF-07817883 was reported in this outcome measure. Rac was calculated as AUCtau on Day 5 or Day 10/AUCtau on Day 1.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
1.163 Ratio
Geometric Coefficient of Variation 18
|
0.8962 Ratio
Geometric Coefficient of Variation 20
|
0.9605 Ratio
Geometric Coefficient of Variation 4
|
0.9412 Ratio
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
|
Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
1.250 Ratio
Geometric Coefficient of Variation 28
|
0.9972 Ratio
Geometric Coefficient of Variation 18
|
1.054 Ratio
Geometric Coefficient of Variation 9
|
1.022 Ratio
Geometric Coefficient of Variation 7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
Rac,Cmax of PF-07817883 was reported in this outcome measure. Rac,Cmax was calculated as Cmax on Day 5 or Day 10/Cmax on Day 1.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
1.183 Ratio
Geometric Coefficient of Variation 22
|
1.075 Ratio
Geometric Coefficient of Variation 30
|
1.142 Ratio
Geometric Coefficient of Variation 33
|
0.9844 Ratio
Geometric Coefficient of Variation 18
|
—
|
—
|
—
|
|
Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
0.9744 Ratio
Geometric Coefficient of Variation 20
|
0.8471 Ratio
Geometric Coefficient of Variation 36
|
0.9717 Ratio
Geometric Coefficient of Variation 18
|
0.8712 Ratio
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
PTR of PF-07817883 was reported in this outcome measure. PTR was calculated as Cmax/Cmin.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
10.88 Ratio
Geometric Coefficient of Variation 10
|
13.47 Ratio
Geometric Coefficient of Variation 21
|
10.60 Ratio
Geometric Coefficient of Variation 49
|
13.22 Ratio
Geometric Coefficient of Variation 10
|
—
|
—
|
—
|
|
Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
8.566 Ratio
Geometric Coefficient of Variation 14
|
11.05 Ratio
Geometric Coefficient of Variation 30
|
10.13 Ratio
Geometric Coefficient of Variation 23
|
12.46 Ratio
Geometric Coefficient of Variation 9
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 5 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12 hours post-dose) and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable at specified timepoints.
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10
Day 5
|
—
|
10.83 Liter/hour (L/hr)
Geometric Coefficient of Variation 15
|
16.57 Liter/hour (L/hr)
Geometric Coefficient of Variation 10
|
13.12 Liter/hour (L/hr)
Geometric Coefficient of Variation 22
|
15.88 Liter/hour (L/hr)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
|
Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10
Day 10
|
—
|
11.60 Liter/hour (L/hr)
Geometric Coefficient of Variation 10
|
17.13 Liter/hour (L/hr)
Geometric Coefficient of Variation 8
|
14.37 Liter/hour (L/hr)
Geometric Coefficient of Variation 18
|
17.32 Liter/hour (L/hr)
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau\*kel).
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10
|
—
|
200.1 Liter
Geometric Coefficient of Variation 84
|
279.6 Liter
Geometric Coefficient of Variation 62
|
198.1 Liter
Geometric Coefficient of Variation 98
|
186.0 Liter
Geometric Coefficient of Variation 115
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10
|
—
|
13.95 Hours
Standard Deviation 9.3938
|
13.01 Hours
Standard Deviation 8.8563
|
11.44 Hours
Standard Deviation 6.8367
|
8.587 Hours
Standard Deviation 5.8524
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 (0 to 12 hours)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Aetau was defined as amount excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau of PF-07817883 was reported in this outcome measure. Aetau was calculated as sum of (urine volume\*urine concentration) for each collection over the dosing interval.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10
|
—
|
18.47 Milligram (mg)
Geometric Coefficient of Variation 16
|
96.86 Milligram (mg)
Geometric Coefficient of Variation 5
|
373.2 Milligram (mg)
Geometric Coefficient of Variation 10
|
85.85 Milligram (mg)
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 (0 to 12 hours)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Aetau% was defined as percentage of dose excreted in urine as unchanged drug over the dosing interval tau, where tau= 12 hours. Aetau% of PF-07817883 was reported in this outcome measure. Aetau% was calculated as 100\*Aetau/dose.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10
|
—
|
9.261 Percentage of Dose Excreted
Geometric Coefficient of Variation 16
|
16.15 Percentage of Dose Excreted
Geometric Coefficient of Variation 5
|
24.90 Percentage of Dose Excreted
Geometric Coefficient of Variation 10
|
14.34 Percentage of Dose Excreted
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 10 (0 to 12 hours)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
CLr of PF-07817883 was reported in this outcome measure. CLr was calculated as Aetau/AUCtau.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=4 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=3 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10
|
—
|
1.074 Liter/hour (L/hr)
Geometric Coefficient of Variation 20
|
2.771 Liter/hour (L/hr)
Geometric Coefficient of Variation 5
|
3.586 Liter/hour (L/hr)
Geometric Coefficient of Variation 26
|
2.477 Liter/hour (L/hr)
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number Analyzed'' signifies participants evaluable for the specified rows. This outcome measure was planned to be analyzed only in the tablet formulation as pre-specified in the protocol.
Data for AUClast and AUCinf are reported in the descriptive section. AUClast was calculated by the linear/log trapezoidal method. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis. Ratio based on AUClast and AUCinf of tablet formulations under fed and fasted conditions were reported in statistical analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition
AUCinf
|
—
|
44140 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
28430 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
42930 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
46170 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
|
Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition
AUClast
|
—
|
43570 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
27750 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
41620 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
35930 Nanogram*Hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the tablet formulation as pre-specified in the protocol.
Data for Cmax are reported in the descriptive section. Ratio based on Cmax of tablet formulation under fed and fasted conditions were reported in statistical analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition
|
—
|
6934 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
4590 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
6284 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
5008 Nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Tmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Time for Cmax (Tmax) of PF-07817883
|
—
|
0.750 Hours
Interval 0.5 to 1.05
|
1.01 Hours
Interval 0.5 to 2.0
|
4.00 Hours
Interval 1.0 to 4.0
|
1.34 Hours
Interval 1.0 to 2.0
|
4.00 Hours
Interval 2.0 to 6.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Cmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Maximum Observed Concentration (Cmax) of PF-07817883
|
—
|
9354 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 18
|
6934 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
4590 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
6284 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
5008 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 47
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
|
—
|
42540 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
43570 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
27750 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
41620 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 41
|
35930 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 54
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=11 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
|
—
|
42970 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
44140 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
28430 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
42930 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
46170 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=11 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Terminal Half-Life (t1/2) of PF-07817883
|
—
|
7.578 Hours
Standard Deviation 3.2536
|
7.957 Hours
Standard Deviation 3.8740
|
10.15 Hours
Standard Deviation 2.2890
|
6.822 Hours
Standard Deviation 3.5964
|
11.07 Hours
Standard Deviation 4.4518
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=11 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Apparent Clearance (CL/F) of PF-07817883
|
—
|
13.97 Liter/hour
Geometric Coefficient of Variation 35
|
13.58 Liter/hour
Geometric Coefficient of Variation 38
|
21.09 Liter/hour
Geometric Coefficient of Variation 28
|
13.98 Liter/hour
Geometric Coefficient of Variation 43
|
12.98 Liter/hour
Geometric Coefficient of Variation 27
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48 hours post-dose)Population: Pharmacokinetic (PK) parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau\*kel).
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=11 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=4 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Apparent Volume of Distribution (Vz/F) of PF-07817883
|
—
|
136.2 Liter
Geometric Coefficient of Variation 55
|
136.7 Liter
Geometric Coefficient of Variation 50
|
302.2 Liter
Geometric Coefficient of Variation 31
|
120.7 Liter
Geometric Coefficient of Variation 55
|
192.8 Liter
Geometric Coefficient of Variation 64
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With TEAEs
|
—
|
4 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Laboratory parameters included: hematology (monocytes/leukocytes \>1.2\*ULN \[%\], partial thromboplastin time \>1.1\*ULN \[seconds\]) and urinalysis (urine hemoglobin \>=1, bacteria \>20 \[/lpf\]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=2 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With Laboratory Test Abnormalities
|
—
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 3 of each periodPopulation: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
n=6 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 3: Number of Participants With ECG Abnormalities
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Tmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Time for Cmax (Tmax) of PF-07817883
|
—
|
0.500 Hours
Interval 0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
Cmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Maximum Observed Concentration (Cmax) of PF-07817883
|
—
|
6791 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported.
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
|
—
|
35520 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 24
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
|
—
|
36910 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Terminal Half-Life (t1/2) of PF-07817883
|
—
|
6.882 Hours
Standard Deviation 3.0621
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
CL/F of PF-07817883 was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Apparent Clearance (CL/F) of PF-07817883
|
—
|
16.26 Liter/hour
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 48, 72 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Vz/F of PF-07817883 was reported in this outcome measure. Vz/F was calculated as dose/(AUCtau\*kel).
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=5 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Apparent Volume of Distribution (Vz/F) of PF-07817883
|
—
|
146.7 Liter
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With TEAEs
|
—
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 47 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Laboratory parameters included: hematology (mean corpuscular volume \<0.9\*LLN \[cubic micrometer {um\^3}\], mean corpuscular hemoglobin \<0.9\*LLN \[picograms per cell {pg/cell}\], monocytes/leukocytes \>1.2\*ULN \[%\]). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With Laboratory Test Abnormalities
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 11Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP value < 90 mmHg
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg increase
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg decrease
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP value < 50 mmHg
|
—
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg increase
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg decrease
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value < 40 bpm
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value > 120 bpm
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 11Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=6 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 4: Number of Participants With ECG Abnormalities
|
—
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Number of Participants With TEAEs
|
—
|
11 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Laboratory parameters included: hematology (lymphocytes \<0.8\*LLN \[10\^3/mm3\], lymphocytes/leukocytes \<0.8\*LLN \[%\], neutrophils/leukocytes \<0.8\*LLN \[%\], monocytes/leukocytes \>1.2\*ULN \[%\]), chemistry (amylase \>1.5\*ULN \[units/liter\] {U/L}), and urinalysis (urine hemoglobin \>=1). Number of participants with any lab test abnormalities meeting the pre-specified criteria are reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=7 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Number of Participants With Laboratory Test Abnormalities
|
—
|
5 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Vital signs including SBP, DBP and PR were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value \< 90 mmHg, change \>= 30 mmHg increase, change \>= 30 mmHg decrease; DBP: value \< 50 mmHg, change \>= 20 mmHg increase, change \>= 20 mmHg decrease; PR: value \< 40 bpm, value \> 120 bpm.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP value < 90 mmHg
|
—
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg increase
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
SBP change >= 30 mmHg decrease
|
—
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg increase
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP change >= 20 mmHg decrease
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value < 40 bpm
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
Pulse rate value > 120 bpm
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria
DBP value < 50 mmHg
|
—
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 65 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF and QRS complex. Number of participants with abnormalities in ECG were reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Number of Participants With ECG Abnormalities
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Tmax of midazolam was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Time for Cmax (Tmax) of Midazolam
|
—
|
0.500 Hours
Interval 0.5 to 1.12
|
0.500 Hours
Interval 0.5 to 1.02
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
AUClast of midazolam was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam
|
—
|
92.37 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 27
|
77.46 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
t1/2 of midazolam was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Terminal Half-Life (t1/2) of Midazolam
|
—
|
6.589 Hours
Standard Deviation 1.6566
|
6.923 Hours
Standard Deviation 1.9185
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
CL/F of midazolam was reported in this outcome measure. CL/F was calculated as dose/AUCinf.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Apparent Clearance (CL/F) of Midazolam
|
—
|
53.02 Liter/hour
Geometric Coefficient of Variation 26
|
62.60 Liter/hour
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for Midazolam 5 mg arm and Day 10 (pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post-dose) for PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg armPopulation: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Vz/F of midazolam was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf\*kel).
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=12 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
n=13 Participants
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam
|
—
|
488.5 Liter
Geometric Coefficient of Variation 44
|
598.9 Liter
Geometric Coefficient of Variation 45
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Cmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Maximum Observed Concentration (Cmax) of PF-07817883
|
—
|
53160 Nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
Tmax of PF-07817883 was reported in this outcome measure.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Time for Cmax (Tmax) of PF-07817883
|
—
|
1.00 Hours
Interval 0.567 to 1.5
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
AUClast of PF-07817883 was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=23 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883
|
—
|
248300 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
AUCinf of PF-07817883 was reported in this outcome measure. AUCinf was calculated as AUClast + (Clast/kel), where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=19 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883
|
—
|
253000 Nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 17
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose)Population: PK parameter set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest were reported. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed only in the PF-07817883 6000 mg (suspension), fasted arm, as pre-specified in the protocol.
t1/2 of PF-07817883 was reported in this outcome measure. t1/2 was calculated by Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. Only those data points judged to describe the terminal log-linear decline were used in the regression.
Outcome measures
| Measure |
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 150 mg (Suspension), Fasted
n=19 Participants
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 500 mg (Suspension), Fed
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
PF-07817883 1500 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 3000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
PF-07817883 4000 mg (Suspension), Fasted
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
|---|---|---|---|---|---|---|---|---|
|
Part 6: Terminal Half-Life (t1/2) of PF-07817883
|
—
|
12.64 Hours
Standard Deviation 7.1787
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 1: Placebo (Suspension), Fasted
Part 1: Placebo (Suspension), Fed
Part 1: PF-07817883 150 mg (Suspension), Fasted
Part 1: PF-07817883 500 mg (Suspension), Fasted
Part 1: PF-07817883 500 mg (Suspension), Fed
Part 1: PF-07817883 1500 mg (Suspension), Fasted
Part 1: PF-07817883 3000 mg (Suspension), Fasted
Part 1: PF-07817883 4000 mg (Suspension), Fasted
Part 2: Placebo (Suspension) BID, Fasted
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
Part 2: Placebo (Suspension) BID, Fasted, Chinese
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
Part 3: PF-07817883 600 mg (Suspension), Fasted
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
Part 4: PF-07817883 600 mg (Suspension), Fasted
Part 5: PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg
Part 5: Midazolam 5 mg
Part 6: Placebo (Suspension), Fasted
Part 6: PF-07817883 6000 mg (Suspension), Fasted
Part 6: Moxifloxacin 400 mg, Fasted
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Placebo (Suspension), Fasted
n=10 participants at risk
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 1: Placebo (Suspension), Fed
n=2 participants at risk
Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
Part 1: PF-07817883 150 mg (Suspension), Fasted
n=6 participants at risk
Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 1: PF-07817883 500 mg (Suspension), Fasted
n=6 participants at risk
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 1: PF-07817883 500 mg (Suspension), Fed
n=4 participants at risk
Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included.
|
Part 1: PF-07817883 1500 mg (Suspension), Fasted
n=6 participants at risk
Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 1: PF-07817883 3000 mg (Suspension), Fasted
n=5 participants at risk
Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 1: PF-07817883 4000 mg (Suspension), Fasted
n=5 participants at risk
Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included.
|
Part 2: Placebo (Suspension) BID, Fasted
n=6 participants at risk
Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 200 mg (Suspension) BID, Fasted
n=4 participants at risk
Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted
n=4 participants at risk
Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted
n=4 participants at risk
Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions.
|
Part 2: Placebo (Suspension) BID, Fasted, Chinese
n=1 participants at risk
Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions.
|
Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese
n=3 participants at risk
Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions.
|
Part 3: PF-07817883 600 mg (Suspension), Fasted
n=12 participants at risk
Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
|
Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted
n=12 participants at risk
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
|
Part 3: PF-07817883 SDD 600 mg (Tablet), Fed
n=6 participants at risk
Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
|
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted
n=12 participants at risk
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required.
|
Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed
n=6 participants at risk
Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack.
|
Part 4: PF-07817883 600 mg (Suspension), Fasted
n=6 participants at risk
Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours.
|
Part 5: PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg
n=13 participants at risk
Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883.
|
Part 5: Midazolam 5 mg
n=13 participants at risk
Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2.
|
Part 6: Placebo (Suspension), Fasted
n=23 participants at risk
Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
|
Part 6: PF-07817883 6000 mg (Suspension), Fasted
n=23 participants at risk
Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
|
Part 6: Moxifloxacin 400 mg, Fasted
n=24 participants at risk
Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
2/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
2/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
COVID-19
|
10.0%
1/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
20.0%
1/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
50.0%
1/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
2/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Urine output decreased
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
1/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
1/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
1/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Vessel puncture site bruise
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
33.3%
1/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Pseudofolliculitis
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
25.0%
1/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
66.7%
2/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
15.4%
2/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
8.3%
1/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
General disorders
Asthenia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Investigations
Urine output increased
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Syncope
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
16.7%
1/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
15.4%
2/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
69.2%
9/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
69.2%
9/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
15.4%
2/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/2 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/5 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/4 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/1 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/3 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/12 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/6 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
7.7%
1/13 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/23 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/24 • Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER