MedTrace Logo

A Study to Learn How a Medicine That Reduces Stomach Acid Affects the Level of Sisunatovir in the Blood of Healthy Adults.

NCT06105983 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-24

No results posted yet for this study

Summary

The purpose of this study is to see how rabeprazole affects the level of the study medicine sisunatovir in the blood of healthy adult participants. Rabeprazole is a medicine that reduces the amount of acid the stomach makes.

The information from this study may inform how sisunatovir will be used in the future with medicines that reduce stomach acid.

This study is seeking healthy participants who:

* are aged 18 years of age or older.
* are confirmed to be healthy by some medical tests. This study can include both men and women. Women who can produce a baby must agree to use a highly effective method of birth control.
* have body mass index (BMI) of 16 to 32 kilograms per meter squared.
* a total body weight of more than 45 kilograms. Participants will receive sisunatovir tablets by mouth on Day 1. After at least 48 hours, participants will take rabeprazole tablets by mouth once a day for 7 days. On the last (7th) day of rabeprazole dosing, another dose of sisunatovir tablets will be taken by mouth.

The study will look at the blood levels of sisunatovir with and without taking rabeprazole. This will help see how sisunatovir should be given in the future.

The total planned time of participation is about 10 to 11 weeks. The study consists of:

* screening period of up to 28 days before taking sisunatovir.
* 13 days of staying in the study clinic.
* a follow-up contact that will occur 28 to 35 days after taking sisunatovir the last time.

Conditions

  • Healthy

Interventions

DRUG

Sisunatovir

Single Dose

DRUG

Rabeprazole 40 mg

Tablets once daily for 7 days

DRUG

Sisunatovir suspension

Tablets once daily for 7 days

DRUG

Rabeprazole 20 mg

Tablets once daily for 7 days

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-03
Primary Completion
2024-07-19
Completion
2024-07-19
FDA Drug
Yes

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06105983 on ClinicalTrials.gov