Trial Outcomes & Findings for A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants. (NCT NCT05994963)
NCT ID: NCT05994963
Last Updated: 2025-05-06
Results Overview
AUClast was calculated using linear/log trapezoidal method. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
COMPLETED
PHASE1
25 participants
Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3
2025-05-06
Participant Flow
Study had 2 parts: Part 1 and Part 2. Total enrolled participants were 25 (Part 1=14 and Part 2=11).
Sisunatovir 200 milligram (mg) single oral dose was administered as powder in capsule (PIC) or wet granulation tablet (WGT) under fasted condition, or as WGT with food. Study had 2 parts: 1 and 2. Part 1, treatments were: A= sisunatovir 200 mg PIC under fasted condition; B = sisunatovir 200 mg WGT under fasted condition; C= sisunatovir 200 mg WGT with a high-fat meal. Part 2, treatments were: B = sisunatovir 200 mg WGT under fasted condition; D= sisunatovir 200 mg WGT with a low-fat meal.
Participant milestones
| Measure |
Part 1: Treatment A Then Treatment B Then Treatment C
Participants received treatment A on Day 1 of Period 1. Period 1 was followed by Period 2, where participants received treatment B on Day 1 of Period 2. Period 2 was followed by Period 3, where participants received treatment C on Day 1 of Period 3.
|
Part 1: Treatment B Then Treatment A Then Treatment C
Participants received treatment B on Day 1 of Period 1. Period 1 was followed by Period 2, where participants received treatment A on Day 1 of Period 2. Period 2 was followed by Period 3, where participants received treatment C on Day 1 of Period 3.
|
Part 2: Treatment B Then Treatment D
Participants received treatment B on Day 1 of Period 1. Period 1 was followed by Period 2, where participants received treatment D on Day 1 of Period 2.
|
Part 2: Treatment D Then Treatment B
Participants received treatment D on Day 1 of Period 1. Period 1 was followed by Period 2, where participants received treatment B on Day 1 of Period 2.
|
|---|---|---|---|---|
|
Part 1: Treatment Period 1
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 1
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1: Treatment Period 2
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 2
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 1: Treatment Period 3
STARTED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 3
COMPLETED
|
7
|
7
|
0
|
0
|
|
Part 1: Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2: Treatment Period 1
STARTED
|
0
|
0
|
5
|
6
|
|
Part 2: Treatment Period 1
COMPLETED
|
0
|
0
|
5
|
6
|
|
Part 2: Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2: Treatment Period 2
STARTED
|
0
|
0
|
5
|
6
|
|
Part 2: Treatment Period 2
COMPLETED
|
0
|
0
|
5
|
6
|
|
Part 2: Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants.
Baseline characteristics by cohort
| Measure |
Part 1: Sisunatovir 200 mg
n=14 Participants
Participants received treatment A or B or C in any period of Part 1.
|
Part 2: Sisunatovir 200 mg
n=11 Participants
Participants received treatment B or D in any period of Part 2.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-44 Years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
45-64 Years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Customized
>=65 Years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: Pharmacokinetic (PK) parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
AUClast was calculated using linear/log trapezoidal method. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to The Time of The Last Quantifiable Concentration (AUClast) of Sisunatovir PIC Versus (vs) WGT in a Fasted State, Part 1
|
646.6 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 97
|
380.5 nanogram*hour per milliliter (ng*hr/ mL)
Geometric Coefficient of Variation 123
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=13 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=13 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of Sisunatovir PIC vs WGT in Fasted State, Part 1
|
784.4 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
457.2 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 104
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
Treatment A = sisunatovir 200 mg PIC under fasted condition; reference treatment. Treatment B = sisunatovir 200 mg WGT under fasted condition; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Sisunatovir PIC vs WGT in a Fasted State, Part 1
|
63.78 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 126
|
31.97 nanogram per milliliter (ng/ mL)
Geometric Coefficient of Variation 179
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
AUClast was calculated using linear/log trapezoidal method. Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment C = sisunatovir 200 mg WGT with high-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
AUClast of Sisunatovir WGT Under Fasted vs With a High-fat Meal, Part 1
|
380.5 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 123
|
770.6 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 88
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment C= sisunatovir 200 mg WGT with high-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=13 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=13 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
AUCinf of Sisunatovir WGT Under Fasted vs With a High-fat Meal, Part 1
|
457.2 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 104
|
896.6 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 68
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment C= sisunatovir 200 mg WGT with high-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Cmax of Sisunatovir WGT Under Fasted vs With a High-fat Meal, Part 1
|
31.97 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 179
|
73.61 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 97
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
AUClast was calculated using linear/log trapezoidal method. Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment D= sisunatovir 200 mg WGT with low-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
AUClast of Sisunatovir WGT Under Fasted vs With a Low-fat Meal, Part 2
|
744.5 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 123
|
916.0 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated. Here "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
AUCinf was calculated as AUClast + (Clast\*/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis, and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment D= sisunatovir 200 mg WGT with low-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=10 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
AUCinf of Sisunatovir WGT Under Fasted vs With a Low-fat Meal, Part 2
|
996.4 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 49
|
957.4 nanogram* hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 62
|
—
|
SECONDARY outcome
Timeframe: Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10,12 hours post-dose on Day 1; 24, 36 hours post-dose on Day 2; 48 hours post-dose on Day 3 of Period 1-3; 72 hours post-dose on Day 4 of period 3Population: PK parameter analysis set included all randomized participants who received at least one dose of study medication and in whom at least 1 plasma PK parameter was calculated.
Treatment B = sisunatovir 200 mg WGT under fasted condition; reference treatment. Treatment D= sisunatovir 200 mg WGT with low-fat meal; test treatment.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Cmax of Sisunatovir WGT Under Fasted vs With a Low-fat Meal, Part 2
|
68.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 97
|
85.88 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment up to 35 days post last dose. Treatment A= sisunatovir 200 mg PIC under fasted condition; treatment B = sisunatovir 200 mg WGT under fasted condition and treatment C= sisunatovir 200 mg WGT with a high-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
n=14 Participants
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 1
|
3 Participants
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 39 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any AEs that occurred following start of treatment up to 35 days post last dose. Treatment B = sisunatovir 200 mg WGT under fasted condition and treatment D= sisunatovir 200 mg WGT with a low-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs): Part 2
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Laboratory parameters included: Hematology (Eosinophils/Leukocytes) and Urinalysis (Urine Hemoglobin). Clinically significant laboratory abnormality findings were based on investigator discretion. Clinical significance was determined by the investigator. Treatment A= sisunatovir 200 mg PIC under fasted condition; treatment B = sisunatovir 200 mg WGT under fasted condition and treatment C= sisunatovir 200 mg WGT with a high-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
n=14 Participants
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 39 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Laboratory parameters included: Hematology (Eosinophils/Leukocytes) and Urinalysis (Urine Hemoglobin). Clinically significant laboratory abnormality findings were based on investigator discretion. Clinical significance was determined by the investigator. Treatment B = sisunatovir 200 mg WGT under fasted condition and treatment D= sisunatovir 200 mg WGT with a low-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities: Part 2
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinically significant vital signs findings were based on investigator discretion. Treatment A= sisunatovir 200 mg PIC under fasted condition; treatment B = sisunatovir 200 mg WGT under fasted condition and treatment C= sisunatovir 200 mg WGT with a high-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
n=14 Participants
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Findings: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 39 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
Vital signs (temperature, respiratory rate, pulse, systolic and diastolic blood pressure) were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinically significant vital signs findings were based on investigator discretion. Treatment B = sisunatovir 200 mg WGT under fasted condition and treatment D= sisunatovir 200 mg WGT with a low-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs Findings: Part 2
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measures pulse rate (PR), QT, and QTc corrected using Fridericia's formula (QTcF) intervals and QRS complex with the participant in a supine position after at least 5 minutes of rest. Following ECG parameters were analyzed: post-dose QTcF interval is increased by ≥60 ms from the baseline and is \>450 ms; or an absolute QT value is ≥500 ms for any scheduled ECG. Clinically significant ECG abnormality findings were based on investigator discretion. Treatment A= sisunatovir 200 mg PIC under fasted condition; treatment B = sisunatovir 200 mg WGT under fasted condition and treatment C= sisunatovir 200 mg WGT with a high-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=14 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
n=14 Participants
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings: Part 1
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 39 days)Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
A standard 12-lead ECGs utilizing limb leads were collected using an ECG machine that automatically calculated the heart rate (HR) and measures pulse rate (PR), QT, and QTc corrected using Fridericia's formula (QTcF) intervals and QRS complex with the participant in a supine position after at least 5 minutes of rest. Following ECG parameters were analyzed: post-dose QTcF interval is increased by ≥60 ms from the baseline and is \>450 ms; or an absolute QT value is ≥500 ms for any scheduled ECG. Clinically significant ECG abnormality findings were based on investigator discretion. Treatment B = sisunatovir 200 mg WGT under fasted condition and treatment D= sisunatovir 200 mg WGT with a low-fat meal.
Outcome measures
| Measure |
Part 1: Treatment A
n=11 Participants
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=11 Participants
Participants received treatment B on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment C
Participants received treatment C on Day 1 of Period 3.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings: Part 2
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Part 1 Treatment A
Part 1 Treatment B
Part 1 Treatment C
Part 2 Treatment B
Part 2 Treatment D
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1 Treatment A
n=14 participants at risk
Participants received treatment A on Day 1 of either Period 1 or Period 2.
|
Part 1 Treatment B
n=14 participants at risk
Participants received treatment B on Day 1 of in either Period 1 or Period 2.
|
Part 1 Treatment C
n=14 participants at risk
Participants received treatment C on Day 1 of Period 3.
|
Part 2 Treatment B
n=11 participants at risk
Participants received treatment B on Day 1 of in either Period 1 or Period 2.
|
Part 2 Treatment D
n=11 participants at risk
Participants received treatment D on Day 1 of either Period 1 or Period 2.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
9.1%
1/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Diarrhoea
|
21.4%
3/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
9.1%
1/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
14.3%
2/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
14.3%
2/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
9.1%
1/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
9.1%
1/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
9.1%
1/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
7.1%
1/14 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
0.00%
0/11 • From start of study treatment on Day 1 up to 35 days after last dose of study drug (maximum up to 43 days for Part 1) and (maximum up to 39 days for Part 2)
|
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