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CompletedNCT06105983Updated Apr 24, 2025

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 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

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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.
02

Conditions studied

  • Healthy
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG).
  • Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg

Exclusion criteria

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.
  • A positive urine drug test at screening or admission.
  • A positive serum pregnancy test at screening and/or positive urine/serum pregnancy test in woman/women of childbearing potential (WOCBP) at Day -1
  • Current use of any prohibited concomitant medication(s) for sisunatovir and/or medication(s) that are contraindicated in the rabeprazole prescribing information.
  • Use of tobacco/nicotine containing products
  • Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm Hg for participants ≥60 years old, following at least 5 minutes of supine rest.
  • Renal impairment as defined by an estimated glomerular filtration rate (eGFR) (units of mL/min/1.73m²) \<60 mL/min(/1.73m²) based on 2021 chronic kidney disease epidemiology (CKD-EPI).
  • Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
  • Alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bili) ≥ 1.05 × upper limit of normal (ULN). Participants with an elevated total bilirubin consistent with Gilbert's Disease should have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Treatment A

    Part 1: Sisunatovir without rabeprazole

    Drug: Sisunatovir

  • Active comparator
    Treatment B

    Part 1: Sisunatovir with 40 mg rabeprazole

    Drug: Sisunatovir · Drug: Rabeprazole 40 mg

  • Active comparator
    Treatment C

    Part 2: Sisunatovir suspension without rabeprazole

    Drug: Sisunatovir suspension

  • Experimental
    Treatment D

    Part 2: Sisunatovir suspension with 20 mg rabeprazole

    Drug: Sisunatovir suspension · Drug: Rabeprazole 20 mg

  • Experimental
    Treatment E

    Part 2: Sisunatovir suspension with 40 mg rabeprazole

    Drug: Rabeprazole 40 mg · Drug: Sisunatovir suspension

Interventions

  • DrugSisunatovir

    Single Dose

  • DrugRabeprazole 40 mg

    Tablets once daily for 7 days

  • DrugSisunatovir suspension

    Tablets once daily for 7 days

  • DrugRabeprazole 20 mg

    Tablets once daily for 7 days

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0 to 72 hour postdose

  2. 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

  3. 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

Secondary outcomes

  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)

    Time frame: Baseline up to 35 days after last dose of study intervention

  2. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Baseline to Study Day 12 (Part 1) or Study Day 20 (Part 2)

  3. 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)

07

Study locations

1 site
  • Pfizer Clinical Research Unit - Brussels
    Brussels, Bruxelles-capitale, Région DE B-1070, Belgium
08

References and documents

Individual participant data

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06105983
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 30, 2023
Start date
Nov 3, 2023
Primary completion
Jul 19, 2024
Completion
Jul 19, 2024
Last update
Apr 24, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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