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

• ClinicalTrials.gov Identifier: NCT06003829
• Recruitment Status: Completed
• First Posted: August 22, 2023
• Last Update Posted: October 31, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Healthy	Drug: Sinsunatovir; Other: Bitrex	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: 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
• Actual Study Start Date: July 31, 2023
• Actual Primary Completion Date: September 20, 2023
• Actual Study Completion Date: September 20, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Belgium

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT06003829
• Other Study ID Numbers: C5241014; 2023-504924-24-00 ( Registry Identifier: CTIS (EU) )
• First Posted: August 22, 2023
• Last Update Posted: October 31, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Denatonium; Aversive Agents; Molecular Mechanisms of Pharmacological Action; Abuse-Deterrent Formulations; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents