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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-504924-24-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about the tastes of different suspensions with the study medicine called PF-07923568 in healthy adult participants. In a suspension, the medicine is mixed with a liquid, usually water, in which it cannot dissolve and therefore remains intact in the form of small particles.
This study is seeking for healthy participants who:
Participants will take sisunatovir prepared in 5 different suspensions and bitrex over two days to see if they are good to taste. Participants will answer a questionnaire after tasting each suspension. The questionnaire will be completed for each suspension. The questionnaire asks participants to test each suspension at 4 different times after tasting and spitting out the suspension. At least 60 minutes will pass between tasting each suspension.
The total planned time period of participation is around 5 to 8 weeks. This includes the screening period of up to 28 days. Followed by first administration of study medicine. Then a 3 day in-patient stay at the study clinic. It also includes a follow-up phone call that happens 28-35 days after the final taste test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental |
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| Treatment B | Experimental |
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| Treatment C | Other | Comparator |
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| Treatment D | Experimental |
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| Treatment E | Experimental |
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| Treatment F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinsunatovir | Drug | Single dose, to be spit out after tasting |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 | 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. | At 1 minute after tasting specified study formulation on Day 1 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 | 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. | At 5 minutes after tasting specified study formulation on Day 1 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants received sisunatovir prepared in 5 different suspensions (formulation A, B, D, E and F) and bitrex (formulation C as comparator).
A total of 12 participants were enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
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| Period 1 (Day 1 of the Study) |
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| Period 2 (Day 1 of the Study) |
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| Period 4 (Day 1 of the Study) |
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| Period 6 (Day 2 of the Study) |
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| Period 7 (Day 2 of the Study) |
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| Period 8 (Day 2 of the Study) |
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Enrolled analysis set included participants if the informed consent was not withdrawn prior to participating in any study activity after screening.
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 1 | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 1 minute after tasting specified study formulation on Day 1 |
Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Formulation A | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2023 | Sep 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2023 | Sep 17, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C043414 | denatonium |
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| Bitrex | Other | Single dose, to be spit out after tasting |
|
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. |
| At 10 minutes after tasting specified study formulation on Day 1 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 | 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. | At 20 minutes after tasting specified study formulation on Day 1 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 | 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. | At 1 minute after tasting specified study formulation on Day 2 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 | 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. | At 5 minutes after tasting specified study formulation on Day 2 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 | 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. | At 10 minutes after tasting specified study formulation on Day 2 |
| Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 | 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. | At 20 minutes after tasting specified study formulation on Day 2 |
| Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days) |
| Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory analysis included were: hematology, chemistry and urinalysis. Clinically significance in laboratory abnormalities were judged by investigator. | 1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days) |
| Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included blood pressure (systolic and diastolic) and pulse rate. Clinically significance in vital sign abnormalities were judged by investigator. | Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days) |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 1 | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 5 minutes after tasting specified study formulation on Day 1 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 1 | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 10 minutes after tasting specified study formulation on Day 1 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 1 | 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. | 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. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 20 minutes after tasting specified study formulation on Day 1 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 1 Minute Post-dose on Day 2 | 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. | 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 2. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 1 minute after tasting specified study formulation on Day 2 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 5 Minutes Post-dose on Day 2 | 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. | 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 2. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 5 minutes after tasting specified study formulation on Day 2 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 10 Minutes Post-dose on Day 2 | 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. | 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 2. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 10 minutes after tasting specified study formulation on Day 2 |
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| Primary | Mean Score of Sensory Attributes Based on Palatability Assessment Questionnaire at 20 Minutes Post-dose on Day 2 | 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. | 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 2. | Posted | Mean | 90% Confidence Interval | Units on a scale | At 20 minutes after tasting specified study formulation on Day 2 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 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). | 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. | Posted | Count of Participants | Participants | Day 1 of receiving formulation up to 35 days after last formulation of the study (up to 37 days) |
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| Secondary | Number of Participants With Clinically Significant Laboratory Abnormalities | Laboratory analysis included were: hematology, chemistry and urinalysis. Clinically significance in laboratory abnormalities were judged by investigator. | 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. | Posted | Count of Participants | Participants | 1 day prior to first formulation (Day -1) up to last formulation on Day 2 (up to 3 days) |
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| Secondary | Number of Participants With Clinically Significant Vital Signs Abnormalities | Vital signs included blood pressure (systolic and diastolic) and pulse rate. Clinically significance in vital sign abnormalities were judged by investigator. | 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. | Posted | Count of Participants | Participants | Day 1 of receiving formulation up to last formulation on Day 2 (up to 2 days) |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Formulation B | 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. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | Formulation C | Participants received single dose of bitrex. Participants had to swirl the formulation in the mouth for approximately 10 seconds, and then spit it out. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| EG004 | 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. | 0 | 12 | 0 | 12 | 1 | 12 |
| EG005 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
| Lip dry | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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