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
Palatability Questionnaire - Mouth feel	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - Bitterness	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - Sweetness	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - Sourness	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - saltiness	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - tongue/mouth burn	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose
Palatability Questionnaire - overall liking	Evaluation with a validated color bar on a scale from 0 to 100. Outcomes will be summarized using descriptive statistics.	1, 5, 10, and 20 minutes after dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Baseline up to 35 days after last dose of study intervention
Number of Participants With Clinical Laboratory Abnormalities	Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Vital Signs	Baseline up to Day 2

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 (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Sensory System Agents; Aversive Agents; Abuse-Deterrent Formulations; 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