NCT06105983

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

A PHASE 1, OPEN-LABEL, TWO-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE EFFECT OF A PROTON PUMP INHIBITOR ON THE PHARMACOKINETICS OF SISUNATOVIR IN HEALTHY ADULT PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-11-03
• Primary completion: 2024-07-19
• Completion: 2024-07-19
• First posted: 2023-10-30
• Last updated: 2025-04-24

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study