NCT03782662

A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
DRUG	Itraconazole	Itraconazole capsules
DRUG	Verapamil	Verapamil tablets
DRUG	Rifampicin	Rifampicin capsules
DRUG	Midazolam	Midazolam oromucosal solution
DRUG	Placebo for RV521	Placebo for RV521 capsules
DRUG	RV521	RV521 capsules

Timeline

• Start date: 2018-11-07
• Primary completion: 2019-03-17
• Completion: 2019-03-17
• First posted: 2018-12-20
• Last updated: 2024-04-22

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study