Trial Outcomes & Findings for A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants (NCT NCT05712460)

Last Updated: 2024-09-19

Results Overview

An adverse event (AE) is any untoward medical occurrence in a participant 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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

From start of treatment to 28-35 days after last dose (maximum upto 66 days)

Results posted on

2024-09-19

Participant Flow

This study was planned to be conducted in 2 cohorts: Cohort 1 and optional Cohort 2. Cohort 1 had 2 parts, Part 1 had 3 periods (Period 1, 2, 3) and Part 2 had 4 periods (Period 4, 5, 6, 7). The optional cohort 2 was not conducted based on the findings for Cohort 1.

A total of 12 participants were enrolled at 1 site in Brussels.

Participant milestones

Participant milestones
Measure	Treatment Sequence: ABDEFGH Sisunatovir 400 mg, Fed (treatment A) was administered once every 12 hours (Q12h) for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E) followed by sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ABDFGHE Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) followed by sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ABDGHEF Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDEFGH Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted Sisunatovir 50 mg, Water (Treatment E) sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDFGHE Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDGHEF Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDEFGH Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDFGHE Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDGHEF Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDEFGH Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDFGHE Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDGHEF Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.
Part 1 Period 1 (4 Days) STARTED	1	1	1	1	1	1	1	1	1	1	1	1
Part 1 Period 1 (4 Days) COMPLETED	1	1	1	1	1	1	1	1	1	1	1	1
Part 1 Period 1 (4 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 1 Period 2 (4 Days) STARTED	1	1	1	1	1	1	1	1	1	1	1	1
Part 1 Period 2 (4 Days) COMPLETED	1	1	1	1	1	1	1	1	1	1	1	1
Part 1 Period 2 (4 Days) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 1 Period 3 (4 Days) STARTED	1	1	1	1	1	1	1	1	1	1	1	1
Part 1 Period 3 (4 Days) COMPLETED	1	1	1	1	1	1	1	0	1	1	1	1
Part 1 Period 3 (4 Days) NOT COMPLETED	0	0	0	0	0	0	0	1	0	0	0	0
Part 2 Period 4 (1 Day) STARTED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 4 (1 Day) COMPLETED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 4 (1 Day) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2 Period 5 (1 Day) STARTED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 5 (1 Day) COMPLETED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 5 (1 Day) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2 Period 6 (1 Day) STARTED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 6 (1 Day) COMPLETED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 6 (1 Day) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Part 2 Period 7 (1 Day) STARTED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 7 (1 Day) COMPLETED	1	1	1	1	1	1	1	0	1	1	1	1
Part 2 Period 7 (1 Day) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Sequence: ABDEFGH Sisunatovir 400 mg, Fed (treatment A) was administered once every 12 hours (Q12h) for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E) followed by sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ABDFGHE Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) followed by sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ABDGHEF Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by sisunatovir 200 mg plus matching placebo, Fed (treatment B) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDEFGH Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted Sisunatovir 50 mg, Water (Treatment E) sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDFGHE Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: ACDGHEF Sisunatovir 400 mg, Fed (treatment A) was administered Q12h for 4 days in Period 1, followed by Placebo, Fed (treatment C) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), Sisunatovir 50 mg, Water (Treatment E), and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDEFGH Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H), on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDFGHE Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F), sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: BLDGHEF Sisunatovir 200 mg, Fed (treatment B) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G), sisunatovir 50 mg in saline (treatment H), sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDEFGH Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg capsule content in water (treatment E), sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDFGHE Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in Formula (treatment F) sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.	Treatment Sequence: CLDGHEF Placebo, Fed (treatment C) was administered Q12h for 4 days in Period 1, followed by Sisunatovir 200 mg, Fed (treatment L) Q12h for 4 days in Period 2 followed by sisunatovir 200 mg, Fasted (treatment D) administered Q12h for 4 days in Period 3. There was a washout period of minimum 7 days between each subsequent period. Participants tasted sisunatovir 50 mg in apple juice (treatment G) and sisunatovir 50 mg in saline (treatment H) and sisunatovir 50 mg capsule content in water (treatment E) and sisunatovir 50 mg in Formula (treatment F) on Day 1 of treatment period 4 to 7. There was a washout of at least 60 minutes between tasting each vehicle.
Part 1 Period 3 (4 Days) Refused further treatment	0	0	0	0	0	0	0	1	0	0	0	0

Baseline Characteristics

A Study to Assess the Safety, Effects and Palatability of Sisunatovir in Healthy Adult Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants Participants who were randomized to either of the treatment sequence and received Sisunatovir 400 mg, Fed (A) Sisunatovir 200 mg, Fed (B), Placebo, Fed (treatment C), Sisunatovir 200 mg, Fasted (D), Sisunatovir 200 mg, Fed (treatment L), Sisunatovir 50 mg, Water (E), Sisunatovir 50 mg, Formula (F), Sisunatovir 50 mg, Apple Juice (G), Sisunatovir 50 mg, Saline (H) in any of the treatment periods were included. Participants were administered either Sisunatovir 200 mg in the fed state, Sisunatovir 400 mg in the fed state or placebo in fed state in Period 1 and 2, Sisunatovir 200 mg in fasted state in Period 3 and tasted Sisunatovir 50 mg capsule in either water, formula, apple juice or saline in Periods 4 to 7.
Age, Continuous	43.3 Years STANDARD_DEVIATION 10.75 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment to 28-35 days after last dose (maximum upto 66 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=6 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water n=11 Participants Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula n=11 Participants Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice n=11 Participants Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline n=11 Participants Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	6 Participants	7 Participants	4 Participants	9 Participants	2 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to Day 5

Laboratory tests included haematology (Monocytes \[10\^9/L\] increase: \> 1.2\* upper limit of normal \[ULN\] and Monocytes/Leukocytes \[percentage\] {%}:\> 1.2\* ULN); clinical chemistry (serum) included Alanine Aminotransferase (units per liter \[U/L\]):\> 3.0\* ULN and Bicarbonate (milliequivalents per liter) (mEq/L): \>1.1\* ULN and in urinalysis (urine Hemoglobin (Scalar) more than equal to (\>=) 1, urine Bilirubin (Scalar) \>= 1, Hyaline Casts (/Low power field \[LPF\]) \>= 1. Number of participants with any clinical laboratory abnormalities is reported in this outcome.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=6 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Number of Participants With Clinical Laboratory Abnormalities: Part 1	2 Participants	2 Participants	4 Participants	5 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 5

Supine blood pressure (BP) was measured with the participant's arm supported at the level of the heart and recorded after approximately 5 minutes of rest. Pulse rate was measured in the brachial/radial artery. Notable abnormal vital sign categories included: Systolic BP: \<90 millimeter of mercury \[mmHg\]; Systolic BP change from baseline: maximum increase and decrease \>=30 mmHg; Diastolic BP \<50 mmHg; Diastolic BP change from baseline: maximum decrease and increase ≥20 mmHg; pulse rate \<40 and \>120 beats per minute. Number of participants with newly occurring notable abnormal vital sign (i.e. change in supine systolic BP \>=30 millimeter of mercury \[mmHg\] increase) is reported in this outcome measure.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=6 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Number of Participants With Newly Occurring Notable Abnormal Vital Signs: Part 1	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Up to Day 7

Standard 12-lead ECGs utilizing limb leads were used to measure PR interval, QT interval, QTc corrected using Fridericia's formula (QTcF), and QRS complex. ECG was performed after the participant had rested quietly for at least 5 minutes in a supine position. Clinical significance was determined by the investigator.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=6 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Findings: Part 1	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Population: Pharmacokinetic (PK) parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported.

Area under the concentration-time profile from time zero to time tau (the dosing interval), where tau = 12 hours for twice a day (BID) dosing.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 1: Part 1	2623 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 30	495.7 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 48	338.4 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 72	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Population: PK parameter analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention and in whom at least 1 of the PK parameters of interest could be reported.

AUCtau(dn) was calculated as AUCtau/Dose.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Dose Normalized AUCtau (AUCtau [dn]) for Day 1: Part 1	6.554 Nanogram*hour/ milliliter/milligram Geometric Coefficient of Variation 30	2.478 Nanogram*hour/ milliliter/milligram Geometric Coefficient of Variation 48	1.691 Nanogram*hour/ milliliter/milligram Geometric Coefficient of Variation 72	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Maximum Observed Plasma Concentration (Cmax) for Day 1: Part 1	410.8 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 20	72.00 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 47	50.09 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 77	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Cmax(dn) was calculated as Cmax/Dose.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Dose Normalized Maximum Plasma Concentration (Cmax [dn]) for Day 1: Part 1	1.028 Nanogram/milliliter/milligram (ng/mL/mg) Geometric Coefficient of Variation 20	0.3602 Nanogram/milliliter/milligram (ng/mL/mg) Geometric Coefficient of Variation 47	0.2507 Nanogram/milliliter/milligram (ng/mL/mg) Geometric Coefficient of Variation 77	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=6 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 1: Part 1	5.00 Hour Interval 3.0 to 5.0	5.00 Hour Interval 3.0 to 5.03	5.00 Hour Interval 4.0 to 6.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 5

Area under the concentration-time profile from time zero to time tau (the dosing interval), where tau = 12 hours for BID dosing.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Day 5: Part 1	7244 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 47	787.6 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 57	678.2 Nanogramhour/ milliliter (nghr/mL) Geometric Coefficient of Variation 51	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3,4, 5, 6, 8 and 12 hours post-dose on Day 5

AUCtau(dn) was calculated as AUCtau/Dose.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
AUCtau(dn) for Day 5: Part 1	18.10 Nanogram*hour/milliliter/milligram Geometric Coefficient of Variation 47	3.939 Nanogram*hour/milliliter/milligram Geometric Coefficient of Variation 57	3.388 Nanogram*hour/milliliter/milligram Geometric Coefficient of Variation 51	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Maximum Observed Plasma Concentration (Cmax) for Day 5: Part 1	811.0 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 41	97.89 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 52	76.92 Nanogram/milliliter (ng/mL) Geometric Coefficient of Variation 53	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Cmax(dn) was calculated as Cmax/Dose.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Cmax(dn) for Day 5: Part 1	2.031 ng/mL/mg Geometric Coefficient of Variation 41	0.4900 ng/mL/mg Geometric Coefficient of Variation 52	0.3847 ng/mL/mg Geometric Coefficient of Variation 53	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Day 5: Part 1	4.00 Hour Interval 3.0 to 5.0	5.00 Hour Interval 3.0 to 5.03	5.00 Hour Interval 3.0 to 6.0	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

CL/F was calculated as Dose/AUCtau.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Apparent Clearance (CL/F) for Day 5: Part 1	55.20 Liter/hour Geometric Coefficient of Variation 47	253.9 Liter/hour Geometric Coefficient of Variation 57	295.2 Liter/hour Geometric Coefficient of Variation 50	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5

Rac for AUC was calculated as AUCtau Day5/AUCtau Day1.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Observed Accumulation Ratio (Rac) for AUC for Day 5: Part 1	2.757 Ratio Geometric Coefficient of Variation 24	1.589 Ratio Geometric Coefficient of Variation 22	2.003 Ratio Geometric Coefficient of Variation 63	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8 and 12 hours post-dose on Day 1 and Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Rac,Cmax was calculated as Cmax Day5/Cmax Day1.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Observed Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) for Day 5: Part 1	1.961 Ratio Geometric Coefficient of Variation 25	1.360 Ratio Geometric Coefficient of Variation 25	1.534 Ratio Geometric Coefficient of Variation 69	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Plasma Decay Half-Life (t1/2) for Day 5: Part 1	9.326 Hour Standard Deviation 1.2781	10.87 Hour Standard Deviation 0.96844	11.15 Hour Standard Deviation 2.0984	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Vz/F was calculated as Dose/(AUCtau \* kel \[Terminal phase rate constant\]).

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=5 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=12 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Apparent Volume of Distribution (Vz/F) for Day 5: Part 1	736.1 Liter Geometric Coefficient of Variation 63	3962 Liter Geometric Coefficient of Variation 63	4676 Liter Geometric Coefficient of Variation 60	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose on Day 5

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=12 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
AUCtau for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1	787.6 ng*hr/mL Geometric Coefficient of Variation 57	678.2 ng*hr/mL Geometric Coefficient of Variation 51	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 5

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=12 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Cmax for Day 5: Evaluation of Food Effect (Sisunatovir 200 mg Fed Versus Fasted): Part 1	97.89 ng/mL Geometric Coefficient of Variation 52	76.92 ng/mL Geometric Coefficient of Variation 53	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of overall liking by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated less overall liking.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2 1 minute	74.7 Units on a scale Interval 59.38 to 90.07	67.9 Units on a scale Interval 57.67 to 78.15	77.6 Units on a scale Interval 66.74 to 88.53	65.7 Units on a scale Interval 55.32 to 76.14	—	—	—	—
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2 5 minutes	78.4 Units on a scale Interval 70.22 to 86.51	73.4 Units on a scale Interval 65.44 to 81.29	71.9 Units on a scale Interval 60.13 to 83.69	62.3 Units on a scale Interval 51.89 to 72.66	—	—	—	—
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2 10 minutes	77.6 Units on a scale Interval 70.72 to 84.55	73.6 Units on a scale Interval 65.14 to 82.13	70.1 Units on a scale Interval 58.76 to 81.42	63.0 Units on a scale Interval 52.94 to 73.06	—	—	—	—
Assessment of Overall Liking Based on Palatability Assessment Questionnaire: Part 2 20 minutes	75.0 Units on a scale Interval 64.66 to 85.34	64.9 Units on a scale Interval 57.84 to 71.98	69.8 Units on a scale Interval 58.12 to 81.52	55.0 Units on a scale Interval 47.82 to 62.18	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of mouth feel by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated worse mouth feel.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2 20 minutes	79.1 Units on a scale Interval 71.72 to 86.46	69.0 Units on a scale Interval 61.56 to 76.44	67.5 Units on a scale Interval 57.89 to 77.2	54.5 Units on a scale Interval 46.33 to 62.58	—	—	—	—
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2 1 minute	80.9 Units on a scale Interval 72.49 to 89.33	68.4 Units on a scale Interval 59.1 to 77.62	66.1 Units on a scale Interval 56.71 to 75.47	68.7 Units on a scale Interval 55.14 to 82.31	—	—	—	—
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2 5 minutes	78.5 Units on a scale Interval 69.91 to 87.0	75.4 Units on a scale Interval 67.95 to 82.78	69.5 Units on a scale Interval 61.7 to 77.39	70.1 Units on a scale Interval 58.48 to 81.7	—	—	—	—
Assessment of Mouth Feel Based on Palatability Assessment Questionnaire: Part 2 10 minutes	76.9 Units on a scale Interval 69.98 to 83.84	76.7 Units on a scale Interval 68.65 to 84.8	69.8 Units on a scale Interval 60.61 to 79.03	60.3 Units on a scale Interval 49.75 to 70.8	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of bitterness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more bitterness.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2 20 minutes	77.9 Units on a scale Interval 70.25 to 85.57	68.7 Units on a scale Interval 59.53 to 77.93	73.1 Units on a scale Interval 63.37 to 82.82	53.5 Units on a scale Interval 42.66 to 64.43	—	—	—	—
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2 1 minute	75.3 Units on a scale Interval 61.82 to 88.72	73.5 Units on a scale Interval 63.78 to 83.13	76.0 Units on a scale Interval 65.36 to 86.64	64.2 Units on a scale Interval 50.88 to 77.48	—	—	—	—
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2 5 minutes	78.8 Units on a scale Interval 68.51 to 89.12	75.0 Units on a scale Interval 66.51 to 83.49	76.0 Units on a scale Interval 67.89 to 84.11	59.8 Units on a scale Interval 47.62 to 72.02	—	—	—	—
Assessment of Bitterness Based on Palatability Assessment Questionnaire: Part 2 10 minutes	76.8 Units on a scale Interval 68.93 to 84.7	77.5 Units on a scale Interval 68.71 to 86.38	75.9 Units on a scale Interval 66.97 to 84.85	58.1 Units on a scale Interval 46.35 to 69.84	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of tongue/mouth burn by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more tongue/mouth burn.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2 10 minutes	38.6 Units on a scale Interval 19.62 to 57.65	25.0 Units on a scale Interval 6.38 to 43.62	25.3 Units on a scale Interval 5.18 to 45.37	24.6 Units on a scale Interval 10.32 to 38.95	—	—	—	—
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2 20 minutes	35.8 Units on a scale Interval 16.58 to 55.05	23.6 Units on a scale Interval 6.64 to 40.63	23.1 Units on a scale Interval 6.37 to 39.81	24.4 Units on a scale Interval 10.13 to 38.6	—	—	—	—
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2 1 minute	22.6 Units on a scale Interval 5.95 to 39.32	17.9 Units on a scale Interval 3.34 to 32.48	20.5 Units on a scale Interval 4.84 to 36.07	26.3 Units on a scale Interval 8.91 to 43.63	—	—	—	—
Assessment of Tongue/Mouth Burn Based on Palatability Assessment Questionnaire: Part 2 5 minutes	32.6 Units on a scale Interval 15.17 to 50.1	24.1 Units on a scale Interval 6.8 to 41.38	21.2 Units on a scale Interval 4.91 to 37.45	26.5 Units on a scale Interval 10.37 to 42.72	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of sourness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated increase in sourness.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2 1 minute	53.5 Units on a scale Interval 34.11 to 72.79	32.8 Units on a scale Interval 13.9 to 51.74	45.5 Units on a scale Interval 28.51 to 62.58	34.6 Units on a scale Interval 18.47 to 50.8	—	—	—	—
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2 5 minutes	52.3 Units on a scale Interval 33.83 to 70.71	45.5 Units on a scale Interval 25.77 to 65.14	46.9 Units on a scale Interval 28.33 to 65.49	28.8 Units on a scale Interval 13.33 to 44.31	—	—	—	—
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2 10 minutes	49.5 Units on a scale Interval 31.01 to 67.9	38.3 Units on a scale Interval 18.12 to 58.43	44.0 Units on a scale Interval 24.71 to 63.29	29.2 Units on a scale Interval 13.58 to 44.79	—	—	—	—
Assessment of Sourness Based on Palatability Assessment Questionnaire: Part 2 20 minutes	50.3 Units on a scale Interval 34.5 to 66.05	35.7 Units on a scale Interval 17.11 to 54.34	44.9 Units on a scale Interval 26.06 to 63.76	29.1 Units on a scale Interval 14.13 to 44.05	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of saltiness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more saltiness.

Outcome measures

Outcome measures
Measure	Part 1: Sisunatovir 400 mg, Fed n=11 Participants Participants were administered sisunatovir 400 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fed n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose as 50 mg capsules in a fed state in either period 1 or 2 of Part 1.	Part 1: Placebo, Fed n=11 Participants Participants were administered placebo once every 12 hours for 4 days plus 1 dose in a fed state in either period 1 or 2 of Part 1.	Part 1: Sisunatovir 200 mg, Fasted n=11 Participants Participants were administered sisunatovir 200 mg once every 12 hours for 4 days plus 1 dose in a fasted state in period 3 of Part 1.	Part 2: Sisunatovir 50 mg, Water Participants tasted sisunatovir 50 mg capsule content in water and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Formula Participants tasted sisunatovir 50 mg capsule content in formula and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Apple Juice Participants tasted sisunatovir 50 mg capsule content in Apple Juice and then spat out the drug to assess the palatability.	Part 2: Sisunatovir 50 mg, Saline Participants tasted sisunatovir 50 mg capsule content in saline and then spat out the drug to assess the palatability.
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2 10 minutes	33.4 Units on a scale Interval 16.22 to 50.5	30.0 Units on a scale Interval 14.55 to 45.45	30.6 Units on a scale Interval 15.06 to 46.21	46.8 Units on a scale Interval 31.99 to 61.65	—	—	—	—
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2 20 minutes	32.3 Units on a scale Interval 15.1 to 49.44	32.1 Units on a scale Interval 15.55 to 48.63	29.2 Units on a scale Interval 12.27 to 46.09	46.8 Units on a scale Interval 32.61 to 61.03	—	—	—	—
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2 1 minute	34.8 Units on a scale Interval 17.12 to 52.51	26.7 Units on a scale Interval 10.63 to 42.83	36.0 Units on a scale Interval 18.18 to 53.82	56.4 Units on a scale Interval 37.57 to 75.16	—	—	—	—
Assessment of Saltiness Based on Palatability Assessment Questionnaire: Part 2 5 minutes	39.1 Units on a scale Interval 19.22 to 58.96	34.8 Units on a scale Interval 17.94 to 51.69	38.3 Units on a scale Interval 19.31 to 57.24	49.8 Units on a scale Interval 33.79 to 65.85	—	—	—	—

SECONDARY outcome

Timeframe: 1 minute (immediately following dose), 5,10 and 20 minutes after tasting dose in each vehicle

Participants were required to answer the palatability attribute of sweetness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), Participants were required to answer the palatability attribute of sweetness by providing a mark on the colour bar. The data was rescaled to a score ranging from 0 (good) to 100 (bad), where higher scores indicated more sweetness.