Trial Outcomes & Findings for A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants. (NCT NCT05878522)
NCT ID: NCT05878522
Last Updated: 2024-12-06
Results Overview
The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
43 participants
Primary outcome timeframe
Baseline, Day 3
Results posted on
2024-12-06
Participant Flow
This study was conducted at a single site in the United States. A total of 43 participants were assigned in this study.
Participant milestones
| Measure |
Sisunatovir 300 mg Followed by (=>) Placebo + Moxifloxacin 400mg => Placebo
Healthy participants administered 5 doses of sisunatovir 300 milligram (mg) capsule orally every 12 hours (Q12) over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 300 mg => Placebo => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg => Placebo
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg => Placebo
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg => Placebo
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 300 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 350 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 300 mg => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Treatment Period- 1 (3 Days)
STARTED
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2
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2
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5
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5
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2
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4
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2
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5
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3
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5
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3
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5
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Treatment Period- 1 (3 Days)
COMPLETED
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2
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2
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5
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5
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2
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4
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2
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5
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2
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5
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3
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5
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Treatment Period- 1 (3 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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Washout Period-1 (7 Days)
STARTED
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2
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2
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5
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5
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2
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4
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2
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5
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2
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5
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3
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5
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Washout Period-1 (7 Days)
COMPLETED
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2
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2
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5
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5
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2
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4
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2
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5
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2
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5
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3
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5
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Washout Period-1 (7 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period- 2 (3 Days)
STARTED
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2
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2
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5
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5
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2
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4
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2
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5
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2
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5
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5
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Treatment Period- 2 (3 Days)
COMPLETED
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1
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1
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5
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4
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1
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4
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2
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5
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2
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4
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3
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5
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Treatment Period- 2 (3 Days)
NOT COMPLETED
|
1
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1
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0
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1
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1
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0
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0
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0
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0
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1
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0
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0
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Washout Period-2 (7 Days)
STARTED
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1
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1
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5
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4
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1
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4
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2
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5
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2
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4
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5
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Washout Period-2 (7 Days)
COMPLETED
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1
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1
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5
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4
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1
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4
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2
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5
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2
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4
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3
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5
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Washout Period-2 (7 Days)
NOT COMPLETED
|
0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Treatment Period- 3 (3 Days)
STARTED
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1
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1
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5
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4
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1
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4
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2
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5
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2
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4
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3
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5
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Treatment Period- 3 (3 Days)
COMPLETED
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1
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1
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5
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4
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1
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4
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2
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5
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2
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4
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3
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5
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Treatment Period- 3 (3 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Sisunatovir 300 mg Followed by (=>) Placebo + Moxifloxacin 400mg => Placebo
Healthy participants administered 5 doses of sisunatovir 300 milligram (mg) capsule orally every 12 hours (Q12) over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 300 mg => Placebo => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg => Placebo
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg => Placebo
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg => Placebo
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 300 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 350 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 300 mg => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period- 1 (3 Days)
no longer meets eligibility criteria
|
0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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Treatment Period- 2 (3 Days)
Physician Decision
|
1
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0
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0
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0
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0
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0
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0
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0
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0
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1
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0
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0
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|
Treatment Period- 2 (3 Days)
Adverse Event
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0
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1
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0
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1
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0
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0
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0
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0
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0
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0
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0
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0
|
|
Treatment Period- 2 (3 Days)
Withdrawal by Subject
|
0
|
0
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0
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0
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1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Effects of Sisunatovir on QTc Interval in Healthy Adult Participants.
Baseline characteristics by cohort
| Measure |
Sisunatovir 300 mg Followed by (=>) Placebo + Moxifloxacin 400mg => Placebo
n=2 Participants
Healthy participants administered 5 doses of sisunatovir 300 milligram (mg) capsule orally every 12 hours (Q12) over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 300 mg => Placebo => Placebo + Moxifloxacin 400 mg
n=2 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg => Placebo
n=5 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Sisunatovir 350 mg => Placebo => Placebo + Moxifloxacin 400 mg
n=5 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg
n=3 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg
n=5 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 300 mg => Placebo + Moxifloxacin 400 mg
n=3 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo => Sisunatovir 350 mg => Placebo + Moxifloxacin 400 mg
n=5 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 300 mg => Placebo
n=2 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Sisunatovir 350 mg => Placebo
n=4 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 2. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 300 mg
n=2 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Placebo + Moxifloxacin 400 mg => Placebo => Sisunatovir 350 mg
n=5 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in Period 1. Followed by 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in Period 2. Followed by 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in Period 3. There was washout period of minimum 7 days between doses.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.00 Years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
37.00 Years
STANDARD_DEVIATION 7.07 • n=7 Participants
|
42.20 Years
STANDARD_DEVIATION 13.57 • n=5 Participants
|
41.00 Years
STANDARD_DEVIATION 10.79 • n=4 Participants
|
48.67 Years
STANDARD_DEVIATION 11.72 • n=21 Participants
|
45.40 Years
STANDARD_DEVIATION 11.72 • n=8 Participants
|
50.00 Years
STANDARD_DEVIATION 9.54 • n=8 Participants
|
38.40 Years
STANDARD_DEVIATION 14.43 • n=24 Participants
|
37.00 Years
STANDARD_DEVIATION 1.41 • n=42 Participants
|
42.00 Years
STANDARD_DEVIATION 11.28 • n=42 Participants
|
60.00 Years
STANDARD_DEVIATION 2.83 • n=42 Participants
|
45.40 Years
STANDARD_DEVIATION 16.09 • n=42 Participants
|
43.30 Years
STANDARD_DEVIATION 11.84 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
15 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
28 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
32 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
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
|
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
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 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
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=36 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
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
18 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 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
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 3Population: The concentration QTc analysis set was defined as all participants randomized and treated with sisunatovir or placebo who had at least 1 pair of time-matched post-dose QT and sisunatovir plasma concentration values in at least 1 period of the study. For placebo treatment, the concentration was set to 0. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
The relationship between sisunatovir plasma concentration and change from baseline in Fridericia's heart-rate corrected QT interval were analyzed using a model-based concentration-QTc analysis consistent with the Scientific White Paper on Concentration-QT Modeling. Baseline was defined as the mean of the 3 averages of the triplicate electrocardiogram (ECG) measurements taken before dosing on Day 1 within each period. Mean and CI statistics were based on the individual (within subject) corrected differences between sisunatovir and placebo exposures.
Outcome measures
| Measure |
Sisunatovir 300 mg
n=13 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Placebo-Adjusted Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) at Expected Maximum Concentration (Cmax) on Day 3 for Sisunatovir
|
0.13 Milli seconds (msec)
Interval -1.6 to 1.86
|
-0.93 Milli seconds (msec)
Interval -3.44 to 1.58
|
—
|
—
|
SECONDARY outcome
Timeframe: From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)Population: Safety analysis population 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, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
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 adverse event was considered a Treatment-Emergent Adverse Event (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 but before the end of the study were considered as TEAEs.
Outcome measures
| Measure |
Sisunatovir 300 mg
n=13 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
n=41 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
n=39 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
8 Participants
|
9 Participants
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Day 23Population: Safety analysis population 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, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Standard 12-lead ECGs were performed after the participant had rested quietly for at least 5 minutes in a supine position using an ECG machine that automatically calculated the heart rate and measured PR interval, QT interval, QTcF, and QRS complex. Clinical significance was determined based on investigator's discretion. Baseline of ECG parameters was defined as average of the triplicate ECGs collected at each time point before dosing on Day 1 within each period.
Outcome measures
| Measure |
Sisunatovir 300 mg
n=13 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
n=41 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
n=39 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Day 23Population: Safety analysis population 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, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured with the participant in a supine position after at least 5 minutes of rest. Vital signs were categorized as 1) supine diastolic blood pressure (DBP) minimum (min) less than (\<)50 and maximum (max) increase greater than or equal to (\>=) 20 millimeter of mercury (mmHg); 2) supine systolic blood pressure (SBP) max. decrease \>=20 and min. \<90 (mmHg).
Outcome measures
| Measure |
Sisunatovir 300 mg
n=13 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
n=41 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
n=39 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Number of Participants Meeting Pre-defined Criteria for Vital Signs
Supine diastolic blood pressure (mmHg) min. <50
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Meeting Pre-defined Criteria for Vital Signs
Supine diastolic blood pressure (mmHg) max. increase >=20
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Meeting Pre-defined Criteria for Vital Signs
Supine systolic blood pressure (mmHg) max. decrease >=20
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Meeting Pre-defined Criteria for Vital Signs
Supine systolic blood pressure (mmHg) min. <90
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From Baseline up to Day 23Population: Safety analysis population 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, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
The clinical laboratory tests include hematology, chemistry, urinalysis and other tests. Following parameters were analyzed for laboratory assessments: Hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); Chemistry: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Albumin, Alkaline Phosphatase, Total Bilirubin, Creatinine, Uric Acid, Sodium, Potassium; Glucose(Fasting), Urea, Chloride, Bicarbonates, Total protein; Urinalysis: (decimal logarithm of reciprocal of hydrogen ion activity )\[pH\], Glucose, Protein, Blood, Ketones, Nitrites, Leukocyte esterase; Others tests: Pregnancy test, Urine drug screening, Covid-19 testing. Clinically significant laboratory abnormality findings were based on investigator discretion.
Outcome measures
| Measure |
Sisunatovir 300 mg
n=13 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
n=40 Participants
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
n=39 Participants
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 3, 4 and 5 hours post-dose on Day 3Population: ECG analysis set included all participants who were randomized and treated who have at least 1 post-dose ECG measurement in at least 1 period. This was planned to be reported in moxifloxacin and placebo as pre-specified in protocol. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
Change from baseline in QTcF intervals were analyzed using a MMRM model with sequence, period, treatment, time (post-dose timepoint) and treatment by time interaction as fixed effect, participants within sequence as a random effect and baseline QTcF as a covariate. A compound symmetry covariance matrix was fitted to the repeated times within participant and the Kenward-Roger approximation was used for estimating degrees of freedom.
Outcome measures
| Measure |
Sisunatovir 300 mg
n=39 Participants
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=40 Participants
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3
3 hours post-dose
|
3.97 msec
Interval 1.88 to 6.05
|
-7.77 msec
Interval -9.86 to -5.68
|
—
|
—
|
|
Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3
4 hours post-dose
|
6.63 msec
Interval 4.54 to 8.72
|
-4.72 msec
Interval -6.81 to -2.63
|
—
|
—
|
|
Change From Baseline in QTcF of Moxifloxacin and Placebo at 3, 4 and 5 Hours Post-Dose of Day 3
5 hours post-dose
|
6.84 msec
Interval 4.75 to 8.93
|
-1.52 msec
Interval -3.61 to 0.57
|
—
|
—
|
Adverse Events
Sisunatovir 300 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Sisunatovir 350 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo + Moxifloxacin 400 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sisunatovir 300 mg
n=13 participants at risk
Healthy participants administered 5 doses of sisunatovir 300 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Sisunatovir 350 mg
n=29 participants at risk
Healthy participants administered 5 doses of sisunatovir 350 mg capsule orally every Q12 over 3 days in a fed condition in any of the treatment periods.
|
Placebo
n=41 participants at risk
Healthy participants administered 5 doses of matching placebo orally administered every 12 hours for 2 days in a fed condition in any of the treatment periods.
|
Placebo + Moxifloxacin 400 mg
n=39 participants at risk
Healthy participants administered 4 doses of matching placebo orally administered every Q12 hours for 2 days and a single dose of moxifloxacin 400 mg tablets administered orally on the morning of Day 3 in any of the treatment periods.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
6.9%
2/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
10.3%
3/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
6.9%
2/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Dysphagia
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
6.9%
2/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
13.8%
4/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and 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
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and 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%
0/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
5.1%
2/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Brain fog
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Headache
|
30.8%
4/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
3.4%
1/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
3.4%
1/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
0.00%
0/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and 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%
0/13 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
6.9%
2/29 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.4%
1/41 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
2.6%
1/39 • From start of treatment on Day 1 up to 38 days after last dose of study drug (maximum up to 10 weeks)
Safety population included all participants randomly assigned and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER