- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
-
-
Bruxelles-capitale, Région DE
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Brussels, Bruxelles-capitale, Région DE, Belgium, B-1070
- Recruiting
- Pfizer Clinical Research Unit - Brussels
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment A
Sisunatovir without rabeprazole
|
Single Dose
|
Active Comparator: Treatment B
Sisunatovir with rabeprazole
|
Single Dose
Tablets once daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 0 to 72 hour postdose
|
0 to 72 hour postdose
|
|
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time Frame: 0 to 72 hours postdose
|
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).
|
0 to 72 hours postdose
|
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 0 to 72 hours postdose
|
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
|
0 to 72 hours postdose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time Frame: Baseline up to 35 days after last dose of study intervention
|
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
|
Baseline to Study Day 12
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Baseline to Study Day 12
|
Baseline to Study Day 12
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C5241017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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