NCT05994963

A Study to Compare Different Preparations of Sisunatovir in Healthy Adult Participants.

A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PART CROSSOVER STUDY TO ASSESS THE RELATIVE BIOAVAILABILITY OF SISUNATOVIR FOLLOWING SINGLE ORAL DOSE OF DIFFERENT FORMULATIONS UNDER FED AND FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn how different preparations of sisunatovir are taken up into the blood when taken on an empty stomach or with a meal in healthy adults. This study has two Parts and is seeking participants who: \- are healthy males or females of 18 years of age or older. Part 1: All participants will receive treatments: A, B, and C. The participants will be assigned to take medicines A, B or C by chance, like drawing names out of a hat. All treatments will be taken by mouth. * Participants assigned to treatment A will take four capsules of sisunatovir on empty stomach. * Participants assigned to treatment B will take two sisunatovir tablets on empty stomach. * Participants assigned to treatment C will take two sisunatovir tablets with a high-fat meal. Part 2: All participants will receive treatments: B and D. The participants will be assigned to take medicines B and D by chance, like drawing names out of a hat. All treatments will be taken by mouth. * Participants assigned to treatment B will take two sisunatovir tablets on empty stomach. * Participants assigned to treatment D will take two sisunatovir tablets with a low-fat meal. The participants will be in the study clinic for 10 days in Part 1 and 7 days in Part 2, for: * safety checks, * sample collection for lab tests, * understanding how different preparations of sisunatovir are taken up into the blood when taken on an empty stomach or with a meal. All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are tested to see whether they are fit for the study. The participants can join the study only if they are tested be fit and are interested to take part in the study. The participants will be allowed to go home on Day 10 during Part 1, and on Day 7 during Part 2. About 28 to 35 days after being sent home following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to end the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	sisunatovir	Administered as either capsules in fasted state or tablet in fasted or fed state.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2023-08-16
• Last updated: 2025-05-06
• Results posted: 2025-05-06

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study