Trial Outcomes & Findings for A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants. (NCT NCT06003829)

Last Updated: 2024-11-13

Results Overview

Participants were offered formulation for tasting where they had to swirl sample in their mouth for approximately 10 seconds, and then spit it out. Participant had to assess each sensory attribute on scale of 0 (good) to 100 (bad) after tasting formulation, lower score= better palatability. Following were sensory attributes: mouth feel (grittiness/stickiness or waxiness, 0= normal mouth feel,100=bad mouth feel);bitterness (degree of bitterness of the product, 0= not bitter at all,100= extremely bitter); sweetness(degree of sweet taste,0=sweet, 100= not sweet at all); sourness (degree of sour taste,0= not sour at all,100= extremely sour);saltiness(degree of salty taste,0=not salty at all,100= extremely salty); tongue/mouth burn(degree of tongue/mouth burn,0= no burn at all,100= extreme burn);overall liking (how much like or dislike product, 0= like, 100= dislike).Mean score for each sensory attributes based on palatability assessment questionnaire are reported in this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

At 1 minute after tasting specified study formulation on Day 1

Results posted on

2024-11-13

Participant Flow

A total of 12 participants were enrolled in the study.

Participants received sisunatovir prepared in 5 different suspensions (formulation A, B, D, E and F) and bitrex (formulation C as comparator).

Participant milestones

Participant milestones
Measure	Formulation A Then B Then D Then C Then A Then E Then None Then F Participants were randomized to receive formulation A then B then D and then C in Period 1, 2, 3 and 4 respectively, on Day 1 of the study. On Day 2 of the study participants received formulation A then E then no formulation and then formulation F in Period 5, 6, 7 and 8 respectively. A single dose of each formulation was administered. There was at least 60 minutes interval between each study formulation.	Formulation B Then C Then A Then D Then E Then F Then A Then None Participants were randomized to receive formulation B then C then A and then D in Period 1, 2, 3 and 4 respectively, on Day 1 of the study. On Day 2 of the study participants received formulation E then F then A and then no formulation in Period 5, 6, 7 and 8 respectively. A single dose of each formulation was administered. There was at least 60 minutes interval between each study formulation.	Formulation C Then D Then B Then A Then F Then None Then E Then A Participants were randomized to receive formulation C then D then B and then A in Period 1, 2, 3 and 4 respectively, on Day 1 of the study. On Day 2 of the study participants received formulation F then None then E and then A in Period 5, 6, 7 and 8 respectively. A single dose of each formulation was administered. There was at least 60 minutes interval between each study formulation.	Formulation D Then A Then C Then B Then None Then A Then F Then E Participants were randomized to receive formulation D then A then C then B in Period 1, 2, 3 and 4 respectively, on Day 1 of the study. On Day 2 of the study participants received no formulation then formulation A then F then E in Period 5, 6, 7 and 8 respectively. A single dose of each formulation was administered. There was at least 60 minutes interval between each study formulation.
Period 1 (Day 1 of the Study) STARTED	3	3	3	3
Period 1 (Day 1 of the Study) COMPLETED	3	3	3	3
Period 1 (Day 1 of the Study) NOT COMPLETED	0	0	0	0
Period 2 (Day 1 of the Study) STARTED	3	3	3	3
Period 2 (Day 1 of the Study) COMPLETED	3	3	3	3
Period 2 (Day 1 of the Study) NOT COMPLETED	0	0	0	0
Period 3 (Day 1 of the Study) STARTED	3	3	3	3
Period 3 (Day 1 of the Study) COMPLETED	3	3	3	3
Period 3 (Day 1 of the Study) NOT COMPLETED	0	0	0	0
Period 4 (Day 1 of the Study) STARTED	3	3	3	3
Period 4 (Day 1 of the Study) COMPLETED	3	3	3	3
Period 4 (Day 1 of the Study) NOT COMPLETED	0	0	0	0
Period 5 (Day 2 of the Study) STARTED	3	3	3	3
Period 5 (Day 2 of the Study) COMPLETED	3	3	3	3
Period 5 (Day 2 of the Study) NOT COMPLETED	0	0	0	0
Period 6 (Day 2 of the Study) STARTED	3	3	3	3
Period 6 (Day 2 of the Study) COMPLETED	3	3	3	3
Period 6 (Day 2 of the Study) NOT COMPLETED	0	0	0	0
Period 7 (Day 2 of the Study) STARTED	3	3	3	3
Period 7 (Day 2 of the Study) COMPLETED	3	3	3	3
Period 7 (Day 2 of the Study) NOT COMPLETED	0	0	0	0
Period 8 (Day 2 of the Study) STARTED	3	3	3	3
Period 8 (Day 2 of the Study) COMPLETED	3	3	3	3
Period 8 (Day 2 of the Study) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Learn About the Tastes of Different Suspensions With the Study Medicine (PF-07923568) in Healthy Adult Participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=12 Participants All participants who were enrolled and received study intervention in a randomized crossover manner at each period, up to 4 times a day on Day 1 or Day 2.
Age, Continuous	47.00 Years STANDARD_DEVIATION 18.95 • n=99 Participants
Sex: Female, Male Female	8 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	10 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: At 1 minute after tasting specified study formulation on Day 1

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Data was reported only for those formulations which were administered on Day 1.

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Sourness	32.8 Units on a scale Interval 16.65 to 49.01	30.3 Units on a scale Interval 17.85 to 42.82	50.1 Units on a scale Interval 35.25 to 64.92	32.8 Units on a scale Interval 23.49 to 42.18	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Saltiness	26.1 Units on a scale Interval 13.18 to 38.99	30.8 Units on a scale Interval 18.46 to 43.2	46.6 Units on a scale Interval 30.18 to 62.99	28.0 Units on a scale Interval 17.18 to 38.82	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Tongue/Mouth Burn	14.8 Units on a scale Interval 6.03 to 23.63	18.3 Units on a scale Interval 8.5 to 28.17	27.5 Units on a scale Interval 13.3 to 41.7	21.3 Units on a scale Interval 10.72 to 31.78	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Mouth Feel	54.0 Units on a scale Interval 40.09 to 67.91	48.5 Units on a scale Interval 37.47 to 59.53	80.3 Units on a scale Interval 72.65 to 88.02	49.4 Units on a scale Interval 40.69 to 58.15	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Bitterness	59.5 Units on a scale Interval 47.1 to 71.9	49.4 Units on a scale Interval 34.47 to 64.36	80.2 Units on a scale Interval 73.91 to 86.43	49.8 Units on a scale Interval 36.55 to 62.95	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Sweetness	16.3 Units on a scale Interval 7.46 to 25.04	28.3 Units on a scale Interval 16.59 to 40.08	25.8 Units on a scale Interval 8.89 to 42.61	36.3 Units on a scale Interval 26.57 to 45.93	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 Overall Liking	57.9 Units on a scale Interval 45.23 to 70.6	50.4 Units on a scale Interval 36.49 to 64.35	85.1 Units on a scale Interval 76.58 to 93.59	55.6 Units on a scale Interval 43.51 to 67.65	—	—

PRIMARY outcome

Timeframe: At 5 minutes after tasting specified study formulation on Day 1

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Bitterness	53.5 Units on a scale Interval 42.36 to 64.64	53.2 Units on a scale Interval 40.82 to 65.52	72.3 Units on a scale Interval 61.87 to 82.63	45.9 Units on a scale Interval 37.18 to 54.66	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Sweetness	18.3 Units on a scale Interval 8.72 to 27.95	27.4 Units on a scale Interval 14.88 to 39.95	22.7 Units on a scale Interval 9.28 to 36.05	30.3 Units on a scale Interval 18.94 to 41.56	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Mouth Feel	50.9 Units on a scale Interval 39.47 to 62.36	46.7 Units on a scale Interval 32.36 to 60.97	66.6 Units on a scale Interval 56.85 to 76.31	45.8 Units on a scale Interval 33.91 to 57.59	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Sourness	28.9 Units on a scale Interval 15.76 to 42.08	27.7 Units on a scale Interval 17.09 to 38.24	43.8 Units on a scale Interval 28.95 to 58.71	30.3 Units on a scale Interval 20.83 to 39.83	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Saltiness	24.9 Units on a scale Interval 12.22 to 37.61	24.5 Units on a scale Interval 12.84 to 36.16	34.5 Units on a scale Interval 18.43 to 50.57	23.0 Units on a scale Interval 13.24 to 32.76	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Tongue/Mouth Burn	17.1 Units on a scale Interval 7.42 to 26.75	17.3 Units on a scale Interval 7.37 to 27.13	23.3 Units on a scale Interval 10.5 to 36.16	21.8 Units on a scale Interval 11.07 to 32.6	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 Overall Liking	52.3 Units on a scale Interval 40.97 to 63.7	49.4 Units on a scale Interval 34.27 to 64.56	78.3 Units on a scale Interval 68.19 to 88.31	53.3 Units on a scale Interval 38.59 to 68.07	—	—

PRIMARY outcome

Timeframe: At 10 minutes after tasting specified study formulation on Day 1

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Mouth Feel	40.3 Units on a scale Interval 32.23 to 48.27	44.6 Units on a scale Interval 29.45 to 59.71	62.6 Units on a scale Interval 50.44 to 74.72	43.2 Units on a scale Interval 31.29 to 55.04	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Sourness	24.6 Units on a scale Interval 13.38 to 35.79	18.8 Units on a scale Interval 9.5 to 28.0	42.8 Units on a scale Interval 27.34 to 58.16	29.3 Units on a scale Interval 18.51 to 40.15	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Bitterness	42.0 Units on a scale Interval 34.5 to 49.5	52.7 Units on a scale Interval 36.62 to 68.72	66.2 Units on a scale Interval 52.84 to 79.49	48.0 Units on a scale Interval 39.71 to 56.29	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Sweetness	16.3 Units on a scale Interval 7.09 to 25.41	23.9 Units on a scale Interval 9.52 to 38.32	23.3 Units on a scale Interval 8.96 to 37.71	25.8 Units on a scale Interval 13.87 to 37.63	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Saltiness	21.1 Units on a scale Interval 9.12 to 33.04	22.1 Units on a scale Interval 11.27 to 32.89	34.6 Units on a scale Interval 18.98 to 50.19	22.3 Units on a scale Interval 11.42 to 33.24	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Tongue/Mouth Burn	15.8 Units on a scale Interval 6.09 to 25.57	16.0 Units on a scale Interval 5.18 to 26.82	23.4 Units on a scale Interval 11.2 to 35.63	18.8 Units on a scale Interval 8.54 to 28.96	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 Overall Liking	42.5 Units on a scale Interval 32.88 to 52.12	51.0 Units on a scale Interval 34.37 to 67.63	70.7 Units on a scale Interval 56.77 to 84.57	53.2 Units on a scale Interval 40.38 to 65.96	—	—

PRIMARY outcome

Timeframe: At 20 minutes after tasting specified study formulation on Day 1

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Bitterness	24.0 Units on a scale Interval 15.55 to 32.45	47.8 Units on a scale Interval 31.64 to 64.03	62.7 Units on a scale Interval 48.64 to 76.69	46.0 Units on a scale Interval 35.17 to 56.83	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Sweetness	16.5 Units on a scale Interval 8.2 to 24.8	22.0 Units on a scale Interval 8.62 to 35.38	19.1 Units on a scale Interval 7.53 to 30.64	26.6 Units on a scale Interval 14.9 to 38.26	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Saltiness	18.8 Units on a scale Interval 8.48 to 29.19	21.3 Units on a scale Interval 9.04 to 33.63	33.8 Units on a scale Interval 18.87 to 48.8	18.9 Units on a scale Interval 9.03 to 28.8	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Tongue/Mouth Burn	14.8 Units on a scale Interval 5.59 to 24.08	13.5 Units on a scale Interval 4.11 to 22.89	23.5 Units on a scale Interval 10.16 to 36.84	16.8 Units on a scale Interval 7.33 to 26.17	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Overall Liking	34.7 Units on a scale Interval 25.77 to 43.57	46.8 Units on a scale Interval 29.96 to 63.71	69.4 Units on a scale Interval 53.71 to 85.12	49.4 Units on a scale Interval 36.99 to 61.85	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Mouth Feel	29.8 Units on a scale Interval 20.42 to 39.08	44.5 Units on a scale Interval 28.5 to 60.5	58.3 Units on a scale Interval 45.28 to 71.39	41.5 Units on a scale Interval 28.32 to 54.68	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 Sourness	19.5 Units on a scale Interval 8.98 to 30.02	26.3 Units on a scale Interval 11.96 to 40.54	40.4 Units on a scale Interval 25.64 to 55.19	26.3 Units on a scale Interval 14.97 to 37.7	—	—

PRIMARY outcome

Timeframe: At 1 minute after tasting specified study formulation on Day 2

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Bitterness	48.3 Units on a scale Interval 35.96 to 60.54	—	61.8 Units on a scale Interval 50.27 to 73.23	43.4 Units on a scale Interval 33.09 to 53.74	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Sweetness	38.3 Units on a scale Interval 25.68 to 50.82	—	24.8 Units on a scale Interval 14.14 to 35.53	39.3 Units on a scale Interval 29.25 to 49.25	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Saltiness	28.0 Units on a scale Interval 16.41 to 39.59	—	41.2 Units on a scale Interval 27.39 to 54.94	21.9 Units on a scale Interval 11.17 to 32.67	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Tongue/Mouth Burn	20.1 Units on a scale Interval 8.96 to 31.21	—	22.8 Units on a scale Interval 10.79 to 34.88	20.2 Units on a scale Interval 8.8 to 31.54	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Mouth Feel	46.7 Units on a scale Interval 31.54 to 61.79	—	61.6 Units on a scale Interval 49.91 to 73.25	39.8 Units on a scale Interval 29.68 to 49.99	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Sourness	28.8 Units on a scale Interval 16.81 to 40.86	—	36.7 Units on a scale Interval 25.23 to 48.11	27.0 Units on a scale Interval 15.86 to 38.14	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 Overall Liking	48.3 Units on a scale Interval 32.68 to 63.99	—	68.3 Units on a scale Interval 56.89 to 79.61	42.7 Units on a scale Interval 31.95 to 53.38	—	—

PRIMARY outcome

Timeframe: At 5 minutes after tasting specified study formulation on Day 2

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Saltiness	22.7 Units on a scale Interval 10.99 to 34.35	—	33.6 Units on a scale Interval 19.72 to 47.44	22.3 Units on a scale Interval 11.4 to 33.1	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Mouth Feel	42.3 Units on a scale Interval 27.08 to 57.42	—	53.3 Units on a scale Interval 41.57 to 65.09	38.4 Units on a scale Interval 24.1 to 52.74	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Bitterness	48.7 Units on a scale Interval 34.5 to 62.83	—	61.2 Units on a scale Interval 51.02 to 71.32	46.7 Units on a scale Interval 31.81 to 61.52	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Sweetness	32.8 Units on a scale Interval 20.13 to 45.37	—	21.7 Units on a scale Interval 10.87 to 32.47	29.5 Units on a scale Interval 17.59 to 41.41	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Sourness	26.9 Units on a scale Interval 17.27 to 36.56	—	41.0 Units on a scale Interval 30.06 to 51.94	26.8 Units on a scale Interval 17.45 to 36.21	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Tongue/Mouth Burn	19.7 Units on a scale Interval 8.81 to 30.52	—	20.3 Units on a scale Interval 8.84 to 31.66	19.6 Units on a scale Interval 8.36 to 30.8	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 Overall Liking	44.3 Units on a scale Interval 28.48 to 60.18	—	62.5 Units on a scale Interval 50.35 to 74.65	43.0 Units on a scale Interval 27.13 to 58.87	—	—

PRIMARY outcome

Timeframe: At 10 minutes after tasting specified study formulation on Day 2

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Sweetness	31.3 Units on a scale Interval 18.64 to 44.03	—	20.1 Units on a scale Interval 8.97 to 31.2	27.5 Units on a scale Interval 14.74 to 40.26	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Sourness	22.8 Units on a scale Interval 12.36 to 33.3	—	39.7 Units on a scale Interval 27.79 to 51.54	29.3 Units on a scale Interval 19.41 to 39.09	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Mouth Feel	38.2 Units on a scale Interval 24.25 to 52.08	—	52.5 Units on a scale Interval 40.28 to 64.72	39.0 Units on a scale Interval 24.59 to 53.41	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Bitterness	42.7 Units on a scale Interval 30.51 to 54.83	—	56.9 Units on a scale Interval 44.66 to 69.17	45.1 Units on a scale Interval 31.67 to 58.5	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Saltiness	20.5 Units on a scale Interval 9.38 to 31.62	—	31.5 Units on a scale Interval 18.02 to 44.98	20.4 Units on a scale Interval 9.51 to 31.32	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Tongue/Mouth Burn	19.0 Units on a scale Interval 8.16 to 29.84	—	20.8 Units on a scale Interval 8.76 to 32.74	18.8 Units on a scale Interval 7.92 to 29.58	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 Overall Liking	42.9 Units on a scale Interval 26.72 to 59.11	—	59.3 Units on a scale Interval 45.12 to 73.38	43.2 Units on a scale Interval 27.24 to 59.1	—	—

PRIMARY outcome

Timeframe: At 20 minutes after tasting specified study formulation on Day 2

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Sourness	23.3 Units on a scale Interval 12.91 to 33.75	—	39.8 Units on a scale Interval 27.45 to 52.05	25.3 Units on a scale Interval 16.37 to 34.13	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Overall Liking	38.3 Units on a scale Interval 21.04 to 55.62	—	58.4 Units on a scale Interval 43.08 to 73.76	42.1 Units on a scale Interval 25.84 to 58.33	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Mouth Feel	37.1 Units on a scale Interval 21.61 to 52.55	—	48.9 Units on a scale Interval 36.89 to 60.94	35.6 Units on a scale Interval 21.51 to 49.65	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Bitterness	43.0 Units on a scale Interval 29.76 to 56.24	—	54.2 Units on a scale Interval 41.67 to 66.67	40.8 Units on a scale Interval 27.43 to 54.24	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Sweetness	27.4 Units on a scale Interval 14.9 to 39.94	—	19.2 Units on a scale Interval 8.3 to 30.03	26.2 Units on a scale Interval 12.8 to 39.53	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Saltiness	20.1 Units on a scale Interval 9.73 to 30.43	—	32.0 Units on a scale Interval 18.83 to 45.17	20.2 Units on a scale Interval 9.36 to 30.97	—	—
Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 Tongue/Mouth Burn	18.1 Units on a scale Interval 7.56 to 28.61	—	19.6 Units on a scale Interval 8.17 to 31.0	17.6 Units on a scale Interval 7.08 to 28.08	—	—

SECONDARY outcome

Timeframe: Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days)

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

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that occurred after initiation of study intervention (formulation) that was not present at the time of treatment start up to 35 days after administration of last study intervention (formulation).

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E n=12 Participants Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F n=12 Participants Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days)

Laboratory analysis included were: hematology, chemistry and urinalysis. Clinically significance in laboratory abnormalities were judged by investigator.

Outcome measures

Outcome measures
Measure	Formulation C n=12 Participants Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation D n=12 Participants Participants received single dose of formulation D of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation A n=12 Participants Participants received single dose of formulation A of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation B n=12 Participants Participants received single dose of formulation B of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation E n=12 Participants Participants received single dose of formulation E of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.	Formulation F n=12 Participants Participants received single dose of formulation F of sisunatovir. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out.
Number of Participants With Clinically Significant Laboratory Abnormalities	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days)

Vital signs included blood pressure (systolic and diastolic) and pulse rate. Clinically significance in vital sign abnormalities were judged by investigator.