A Phase 1 interventional study of Sisunatovir and Rabeprazole 40 mg in Healthy, sponsored by Pfizer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by Pfizer · Phase 1, Interventional, and Other
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:
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:
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Part 1: Sisunatovir without rabeprazole
Drug: Sisunatovir
Part 1: Sisunatovir with 40 mg rabeprazole
Drug: Sisunatovir · Drug: Rabeprazole 40 mg
Part 2: Sisunatovir suspension without rabeprazole
Drug: Sisunatovir suspension
Part 2: Sisunatovir suspension with 20 mg rabeprazole
Drug: Sisunatovir suspension · Drug: Rabeprazole 20 mg
Part 2: Sisunatovir suspension with 40 mg rabeprazole
Drug: Rabeprazole 40 mg · Drug: Sisunatovir suspension
Single Dose
Tablets once daily for 7 days
Tablets once daily for 7 days
Tablets once daily for 7 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0 to 72 hour postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Time frame: 0 to 72 hours postdose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0 to 72 hours postdose
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline up to 35 days after last dose of study intervention
Number of Participants With Clinical Laboratory Abnormalities
Time frame: Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)
Plan to share: No — 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.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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