Trial Outcomes & Findings for Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine (NCT NCT04179474)
NCT ID: NCT04179474
Last Updated: 2021-03-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose
Results posted on
2021-03-10
Participant Flow
Participant milestones
| Measure |
Part 1 (Intervention A Then B Then D)
Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2 (Intervention A Then C Then D)
Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|
|
Treatment Period 1 (First Intervention)
STARTED
|
20
|
20
|
|
Treatment Period 1 (First Intervention)
COMPLETED
|
20
|
20
|
|
Treatment Period 1 (First Intervention)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (Second Intervention)
STARTED
|
19
|
20
|
|
Treatment Period 2 (Second Intervention)
COMPLETED
|
19
|
20
|
|
Treatment Period 2 (Second Intervention)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 3 (Third Intervention)
STARTED
|
19
|
19
|
|
Treatment Period 3 (Third Intervention)
COMPLETED
|
19
|
19
|
|
Treatment Period 3 (Third Intervention)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
Baseline characteristics by cohort
| Measure |
Part 1 (Intervention A Then B Then D)
n=20 Participants
Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2 (Intervention A Then C Then D)
n=20 Participants
Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
32.2 years
n=5 Participants
|
38.4 years
n=7 Participants
|
35.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: Pharmacokinetic 1 (PK1) population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time t (AUC0-t) for Ubrogepant Alone and in Combination With Erenumab
|
1841.42 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 490.17
|
1959.96 nanogram*hour/milliliter (ng*h/mL)
Standard Deviation 639.51
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC0-t for Ubrogepant Alone and in Combination With Galcanezumab
|
1700.31 ng*h/mL
Standard Deviation 913.42
|
1758.05 ng*h/mL
Standard Deviation 1033.44
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) for Ubrogepant Alone and in Combination With Erenumab
|
1878.25 ng*h/mL
Standard Deviation 497.82
|
1993.40 ng*h/mL
Standard Deviation 639.22
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: AUC0-∞ for Ubrogepant Alone and in Combination With Galcanezumab
|
1732.22 ng*h/mL
Standard Deviation 928.06
|
1793.74 ng*h/mL
Standard Deviation 1057.02
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Maximum Plasma Drug Concentration (Cmax) for Ubrogepant Alone in Combination With Erenumab
|
459.32 ng/mL
Standard Deviation 168.56
|
486.80 ng/mL
Standard Deviation 201.52
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: Cmax for Ubrogepant Alone and in Combination With Galcanezumab
|
415.34 ng/mL
Standard Deviation 225.64
|
375.12 ng/mL
Standard Deviation 152.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Time of Maximum Plasma Drug Concentration (Tmax) for Ubrogepant Alone and in Combination With Erenumab
|
1.50 hour
Interval 1.0 to 3.0
|
1.48 hour
Interval 0.5 to 3.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: Tmax for Ubrogepant Alone and in Combination With Galcanezumab
|
1.50 hour
Interval 1.0 to 6.0
|
1.50 hour
Interval 0.98 to 6.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Elimination Rate Constant (λz) for Ubrogepant Alone and in Combination With Erenumab
|
0.136 1/hour
Standard Deviation 0.025
|
0.156 1/hour
Standard Deviation 0.034
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: λz for Ubrogepant Alone and in Combination With Galcanezumab
|
0.150 1/hour
Standard Deviation 0.053
|
0.165 1/hour
Standard Deviation 0.056
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Terminal Elimination Half-life (T½) for Ubrogepant Alone and in Combination With Erenumab
|
5.26 hour
Standard Deviation 1.00
|
4.62 hour
Standard Deviation 0.94
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: T½ for Ubrogepant Alone and in Combination With Galcanezumab
|
5.04 hour
Standard Deviation 1.47
|
4.60 hour
Standard Deviation 1.35
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F) for Ubrogepant Alone and in Combination With Erenumab
|
57.35 liter/hour
Standard Deviation 17.20
|
54.74 liter/hour
Standard Deviation 16.27
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: CL/F for Ubrogepant Alone and in Combination With Galcanezumab
|
72.90 liter/hour
Standard Deviation 38.07
|
68.94 liter/hour
Standard Deviation 28.12
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 1: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) for Ubrogepant Alone in Combination With Erenumab
|
436.95 liter
Standard Deviation 158.11
|
375.84 liter
Standard Deviation 161.42
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (Treatment Period 1): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdose; Day 12 (Day 1 of Treatment Period 3): Predose, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 14, and 24 hours postdosePopulation: PK1 population included all participants who had evaluable plasma PK parameters of ubrogepant for both ubrogepant alone and ubrogepant in combination with erenumab or galcanezumab.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Part 2: Vz/F for Ubrogepant Alone in Combination With Galcanezumab
|
568.66 liter
Standard Deviation 497.92
|
449.26 liter
Standard Deviation 213.84
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End of Dosing (EOD): Within 7 days of Day 16 or at the time of early termination (Up to Day 16)Population: Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.
Vital Signs included assessments of Blood Pressure, Pulse Rate, Weight, Respiratory Rate and Temperature. The investigator determined if the postbaseline Vital Sign values were potentially clinically significant using the Vital Sign PCS Criteria in the Statistical Analysis Plan (SAP).
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=20 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16); Follow-up Visit 30 days after last dose (Up to Day 45 +/-3 days)Population: Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.
Laboratory assessments included Chemistry, Hematology and Urinalysis tests. The investigator determined if the postbaseline laboratory results were potentially clinically significant using the Clinical Laboratory PCS Criteria in the SAP. Assessments of Chemistry only were collected at the Final Follow-up Visit
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=20 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had PCS Postbaseline Laboratory Values
Urinalysis; EOD
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had PCS Postbaseline Laboratory Values
Hematology; EOD
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had PCS Postbaseline Laboratory Values
Chemistry; EOD
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Who Had PCS Postbaseline Laboratory Values
Chemistry; Follow-up Visit
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)Population: As per the SAP, abnormalities in physical examinations during the study were captured in medical history or Adverse Events (AEs) data panels. Therefore, there were no separate analyses for physical examination planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: EOD: Within 7 days of Day 16 or at the time of early termination (Up to Day 16)Population: Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.
A standard 12-lead ECG was performed. The investigator determined if the ECG postbaseline values were potentially clinically significant using the ECG PCS Criteria in the SAP.
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=20 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Number of Participants Who Had PCS Postbaseline Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose to within 30 days after last dose (Up to Day 45 +/-3 days)Population: Safety population included all participants who received/took at least 1 administration of study intervention. Data is reported by intervention actually received.
An AE is any untoward medical occurrence in a patient or a participant using an investigational drug, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. The investigator determined if the AE was causally related to treatment. The investigator determined if the severity of the AE was Mild (transient with minimal intervention that does not interfere with usual activities), Moderate ( usually alleviated with an intervention, interferes with usual activities causing discomfort but does not cause permanent harm) or Severe (interrupts usual activities, affects clinical status or requires intensive intervention).
Outcome measures
| Measure |
Part 1: Ubrogepant Alone
n=20 Participants
Participants received Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Ubrogepant in Combination With Erenumab
n=19 Participants
Participants received Intervention B: SC injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally on Day 12 under fasted conditions.
|
Part 1: Intervention D (Ubrogepant)
n=19 Participants
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2: Intervention A (Ubrogepant)
n=20 Participants
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
n=20 Participants
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
n=19 Participants
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
AEs by Severity: Mild
|
7 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
AEs by Severity: Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
AEs by Severity: Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
Related AEs
|
2 Participants
|
7 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
AEs Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) by Severity, Related AEs and AEs Leading to Discontinuation
All AEs
|
7 Participants
|
8 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
Adverse Events
Part 1: Intervention A (Ubrogepant)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 1: Intervention B (Erenumab)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Part 1: Intervention D (Ubrogepant)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part 2; Intervention A (Ubrogepant)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 2: Intervention C (Galcanezumab)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: Intervention D (Ubrogepant)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: Intervention A (Ubrogepant)
n=20 participants at risk
Intervention A (ubrogepant 100 mg tablet) single oral dose on Day 1 under fasted conditions.
|
Part 1: Intervention B (Erenumab)
n=19 participants at risk
Intervention B (erenumab 140 mg) single SC injection on Day 8.
|
Part 1: Intervention D (Ubrogepant)
n=19 participants at risk
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
Part 2; Intervention A (Ubrogepant)
n=20 participants at risk
Intervention A (ubrogepant 100 mg tablet) orally once daily on Day 1 under fasted conditions.
|
Part 2: Intervention C (Galcanezumab)
n=20 participants at risk
Intervention C (galcanezumab 120 mg) two SC injections on Day 8.
|
Part 2: Intervention D (Ubrogepant)
n=19 participants at risk
Intervention D (ubrogepant 100 mg tablet) orally once daily on Days 12, 13, 14 and 15 under fasted conditions.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
10.5%
2/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
10.5%
2/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
10.5%
2/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
General disorders
Puncture site pain
|
15.0%
3/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
10.0%
2/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
31.6%
6/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
15.0%
3/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
10.5%
2/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.3%
1/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
5.0%
1/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/20 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
0.00%
0/19 • First dose to within 30 days after last dose (Up to Day 45 +/-3 days)
Safety population included all participants who received/took at least 1 administration of study intervention. Data is presented by intervention actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER