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An Adaptive, Part Open-label, Part Randomised Phase 1 Clinical Trial in Healthy Volunteers to Study Drug Interactions With RV521 Including Those Mediated by CYP3A4 and P-glycoprotein
The purpose of this clinical trial is to learn about the interaction of sisunatovir with four medications (midazolam, itraconazole, rifampicin, and verapamil). These medications are known to have specific effects on enzymes and proteins that could influence drug absorption. This study will be conducted in 4 Cohorts: * Cohort 1 will receive midazolam and sisunatovir or placebo, * Cohort 2 will receive Itraconazole and sisunatovir, * Cohort 3 will receive verapamil and sisunatovir, * Cohort 4 will receive rifampicin and sisunatovir. A placebo looks like sisunatovir but does not contain any active medicine in it. This study is looking for health adult participants that meet the following criteria: 1. Caucasians age 18 to 45 years 2. All fertile participants must agree to the use of highly effective contraception 3. Body mass index (BMI) of 18-25.0 kg/m2 4. Male and female participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests. This study consists of 2 parts, Part A and Part B. Part A will enroll up to 104 participants. The design of Part B will be determined after the completion of Part A.
Age
18 - 45 years
Sex
ALL
Healthy Volunteers
Yes
Richmond Pharmacology Ltd
London, United Kingdom
Start Date
November 7, 2018
Primary Completion Date
March 17, 2019
Completion Date
March 17, 2019
Last Updated
April 22, 2024
82
ACTUAL participants
Itraconazole
DRUG
Verapamil
DRUG
Rifampicin
DRUG
Midazolam
DRUG
Placebo for RV521
DRUG
RV521
DRUG
Lead Sponsor
Pfizer
NCT07220109
NCT07092865
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07239583