Healthy Clinical Trial - A Study to Compare Different Preparations of

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Healthy

Clinical Trial Details

NCT number	NCT05994963
Study type	Interventional
Source	Pfizer
Contact
Status	Completed
Phase	Phase 1
Start date	September 1, 2023
Completion date	February 26, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms