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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

94 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)

Results posted on

2024-11-21

Participant Flow

A total of 94 participants were enrolled across Belgium and United States.

Participant milestones

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.
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 5:SequenceAB:Washout1(Upto 2 Days)
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Part 1: Washout 1 (up to 5 Days)
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Part 1: Washout 1 (up to 5 Days)
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Part 1: Washout 1 (up to 5 Days)
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Part 1 Treatment Period 2 (Day 1)
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Part 1 Treatment Period 2 (Day 1)
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Part 1: Washout 2 (up to 5 Days)
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Part 1: Washout 2 (up to 5 Days)
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Part 1: Washout 2 (up to 5 Days)
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Part 1: Treatment Period 3 (Day 1)
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Part 1: Treatment Period 3 (Day 1)
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Part 1: Treatment Period 3 (Day 1)
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Part 2 (up to 10 Days)
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Part 3 Period 1 (Day 1)
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Part 3: Washout 1 (up to 3 Days)
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Part 3: Washout 1 (up to 3 Days)
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Part 3: Washout 1 (up to 3 Days)
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Part 3: Period 2 (Day 1)
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Part 3: Period 2 (Day 1)
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Part 3: Washout 2 (up to 3 Days)
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Part 3: Washout 2 (up to 3 Days)
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Part 3: Washout 3 (up to 3 Days)
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Part 3: Washout 3 (up to 3 Days)
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Part 3: Period 4 (Day 1)
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Part 4 (Day 1 to Day 11)
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Part 4 (Day 1 to Day 11)
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Part 5: Sequence AB: Period 1 (Day 1)
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Part 5: Sequence AB: Period 1 (Day 1)
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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
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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
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0
0
0
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0
0
0
0
0
0
0
0
0
0
0
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0
0
0
Part 6 Period 1 (Day 1)
STARTED
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0
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0
0
4
4
4
4
4
4
Part 6 Period 1 (Day 1)
COMPLETED
0
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0
0
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4
4
4
4
4
4
Part 6 Period 1 (Day 1)
NOT COMPLETED
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0
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0
0
Part 6: Washout 1 (up to 7 Days)
STARTED
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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4
4
4
4
4
4
Part 6: Washout 1 (up to 7 Days)
COMPLETED
0
0
0
0
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
0
0
0
4
4
4
4
4
4
Part 6: Washout 1 (up to 7 Days)
NOT COMPLETED
0
0
0
0
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
0
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0
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0
0
0
0
0
Part 6 Period 2 (Day 1)
STARTED
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
4
4
4
4
4
4
Part 6 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
0
4
4
3
4
4
3
Part 6 Period 2 (Day 1)
NOT COMPLETED
0
0
0
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0
0
0
0
0
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0
0
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1
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1
Part 6: Washout 2 (up to 7 Days)
STARTED
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0
0
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0
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4
4
3
4
4
3
Part 6: Washout 2 (up to 7 Days)
COMPLETED
0
0
0
0
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
0
0
0
4
4
3
4
4
3
Part 6: Washout 2 (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 6 Period 3 (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
3
4
4
3
Part 6 Period 3 (Day 1)
COMPLETED
0
0
0
0
0
0
0
0
0
0
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
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0
0
0
0
0
0
0
0
0
0
0
0
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0
0
0
0
0
0

Reasons for withdrawal

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
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Part 1 Treatment Period 2 (Day 1)
Physician Decision
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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0
0
0
0
0
0
Part 1 Treatment Period 2 (Day 1)
Other
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
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0
0
0
0
0
0
Part 1: Treatment Period 3 (Day 1)
Physician Decision
0
1
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 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

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

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

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 period

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 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

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 period

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

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

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

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 12

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. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.

Outcome measures

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 12

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

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

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

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-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.

The percentage of total dose administered recovered in urine was reported in this outcome measure.

Outcome measures

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-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.

The percentage of total dose administered recovered in feces was reported in this outcome measure.

Outcome measures

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-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.

The percentage of total dose administered recovered in urine and feces was reported in this outcome measure.

Outcome measures

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 arm

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.

Cmax of midazolam was reported in this outcome measure.

Outcome measures

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 arm

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 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

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

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

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 period

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

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 period

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 10

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.

C12 of PF-07817883 was reported in this outcome measure.

Outcome measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 period

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. 4. Number of participants with vital signs meeting any of the pre-defined criteria is reported in this outcome measure.

Outcome measures

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 period

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

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

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

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

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

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

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

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

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

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

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 11

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

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 11

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

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

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

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

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

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 arm

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.

Tmax of midazolam was reported in this outcome measure.

Outcome measures

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 arm

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.

AUClast of midazolam was reported in this outcome measure. AUClast was calculated by the linear/log trapezoidal method.

Outcome measures

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 arm

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 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

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 arm

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 midazolam was reported in this outcome measure. CL/F was calculated as dose/AUCinf.

Outcome measures

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 arm

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 midazolam was reported in this outcome measure. Vz/F was calculated as dose/(AUCinf\*kel).

Outcome measures

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

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

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

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

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

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

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 1: Placebo (Suspension), Fed

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 1: PF-07817883 150 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 1: PF-07817883 500 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 1: PF-07817883 500 mg (Suspension), Fed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 1: PF-07817883 1500 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part 1: PF-07817883 3000 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 1: PF-07817883 4000 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 2: Placebo (Suspension) BID, Fasted

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 2: PF-07817883 200 mg (Suspension) BID, Fasted

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 2: PF-07817883 600 mg (Suspension) BID, Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 2: Placebo (Suspension) BID, Fasted, Chinese

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 3: PF-07817883 600 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 3: PF-07817883 SDD 600 mg (Tablet), Fed

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part 4: PF-07817883 600 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part 5: PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Part 5: Midazolam 5 mg

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Part 6: Placebo (Suspension), Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 6: PF-07817883 6000 mg (Suspension), Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Part 6: Moxifloxacin 400 mg, Fasted

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

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Results disclosure agreements

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