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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-03-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RV521 plus Itraconazole

RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D7 plus Itraconazole 100 mg capsules for oral administration, a 200 mg dose administered once daily on D4 - D10, inclusive

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Itraconazole capsules

RV521

Intervention Type DRUG

RV521 capsules

RV521 plus Verapamil

RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D11 plus Verapamil, 80 mg tablets for oral administration, an 80 mg dose administered TDS daily on D4 - D14, inclusive

Group Type EXPERIMENTAL

Verapamil

Intervention Type DRUG

Verapamil tablets

RV521

Intervention Type DRUG

RV521 capsules

RV521 plus Rifampicin

RV521 drug substance in capsule for oral administration, a single 200 mg dose administered on D1 and a single 200 mg dose administered on D10 plus Rifadin, Rifampicin, 300 mg capsules for oral administration, a 600 mg dose administered once daily on D4 - D10, inclusive

Group Type EXPERIMENTAL

Rifampicin

Intervention Type DRUG

Rifampicin capsules

RV521

Intervention Type DRUG

RV521 capsules

RV521 plus Midazolam

RV521 drug substance in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Midazolam oromucosal solution

RV521

Intervention Type DRUG

RV521 capsules

Placebo plus Midazolam

Placebo for RV521 in capsule for oral administration, 200 mg dose administered BID on D2 - D15, inclusive plus Buccolam 10 mg oromucosal solution of midazolam, oral syringes, a single 10 mg dose administered on D1 and a single 200 mg dose administered on D15

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type DRUG

Midazolam oromucosal solution

Placebo for RV521

Intervention Type DRUG

Placebo for RV521 capsules

Interventions

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Itraconazole

Itraconazole capsules

Intervention Type DRUG

Verapamil

Verapamil tablets

Intervention Type DRUG

Rifampicin

Rifampicin capsules

Intervention Type DRUG

Midazolam

Midazolam oromucosal solution

Intervention Type DRUG

Placebo for RV521

Placebo for RV521 capsules

Intervention Type DRUG

RV521

RV521 capsules

Intervention Type DRUG

Other Intervention Names

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Rifadin Midazolam Prefilled Syringe Buccolam

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 45 years, inclusive
* Willing to comply with protocol defined contraception requirements
* In good health with no history of major medical conditions
* A body mass index (BMI) of 18 - 25 kg/m2

Exclusion Criteria

* Evidence of any clinically significant or currently active major medical condition
* Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
* Not willing to comply with protocol defined restrictions for intake of drugs of abuse, alcohol, nicotine-containing products, medication (prescription, OTC, herbal, vitamins/minerals etc) and specified food and drink products

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes