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

NCT03782662 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-04-22

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2019-03-17
Completion
2019-03-17
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782662 on ClinicalTrials.gov