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

A RANDOMIZED, PHASE 1, SINGLE-BLIND, MULTI-PERIOD STUDY TO INVESTIGATE THE PALATABILITY OF PF-07923568 ORAL SUSPENSION IN DIFFERENT LIQUID VEHICLES IN HEALTHY ADULT PARTICIPANTS

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:

• are aged 18 years of age or older.
• can produce a baby must agree to use a highly effective method of birth control.
• are confirmed to be healthy by some medical tests. This study can include both men and women.
• have body mass index (BMI) of 16 to 32 kg/m2 and a total body weight of more than 45 kilograms.

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sinsunatovir; Other: Bitrex

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région DE
    • Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).
• Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Conditions that affect ability to taste eg, dysgeusia, respiratory infection, cold, etc.
• History of hypersensitivity to the active compounds or to any inactive ingredients (excipients) contained in the formulations.
• Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
• A positive urine drug test at screening or admission.
• A positive serum pregnancy test at screening and/or positive urine/serum pregnancy test in woman/women of childbearing potential (WOCBP) at Day -1
• Use of tobacco/nicotine containing products
• Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants <60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
• Renal impairment as defined by an estimated glomerular filtration rate (eGFR) (units of mL/min/1.73m²) <60 mL/min(/1.73m²) based on 2021 chronic kidney disease epidemiology (CKD-EPI).
• Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bili) ≥ 1.05 × upper limit of normal (ULN). Participants with an elevated total bilirubin consistent with Gilbert's Disease should have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: Sinsunatovir; Single dose, to be spit out after tasting
Experimental: Treatment A	Drug: Sinsunatovir; Single dose, to be spit out after tasting
Experimental: Treatment D	Drug: Sinsunatovir; Single dose, to be spit out after tasting
Experimental: Treatment E	Drug: Sinsunatovir; Single dose, to be spit out after tasting
Other: Treatment C; Comparator	Other: Bitrex; Single dose, to be spit out after tasting
Experimental: Treatment F	Drug: Sinsunatovir; Single dose, to be spit out after tasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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).	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)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Actual): September 20, 2023
• Study Completion (Actual): September 20, 2023

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aversive Agents; Abuse-Deterrent Formulations; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Sensory System Agents; Denatonium
• Other Study ID Numbers: C5241014; 2023-504924-24-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No