A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection

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

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-19

Study Completion Date

2017-10-31

Brief Summary

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The purpose of the study is to learn about the safety, pharmacokinetics and antiviral activity of the study medicine (called sisunatovir/RV521) for the potential treatment of respiratory syncytial virus (RSV). Sisunatovir will be given as multiple doses during the treatment period. RSV is a highly contagious virus that can lead to serious lung infections in patients with reduced ability to fight infection. Most vulnerable populations include babies, the elderly and patients that have received a bone marrow transplant.

This study is seeking healthy participants who are:

1. Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception.
2. with a body mass index (BMI) of 18.0 to 30.0 Kg/m2 This study will consist of 2 cohorts of 33 participants each. In both cohorts participants will be exposed to the challenge virus on study day 0. Cohort 1 will receive either 200 mg of sisunatovir or placebo (looks the same as sisunatovir but contains no active medicine) 2 times a day for 5 days. Cohort 2 will receive either 350 mg of sisunatovir or placebo 2 times a day for 5 days. Participants will start taking the study medicine upon confirmation of RSV infection (or evening of Day 5 if not positive to RSV). The study medicine will be administered 12 hours apart (or twice daily). Each participant will remain in the quarantine unit until discharge on Day 12.

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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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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RV521

RV521 drug substance in capsule for oral administration

Group Type EXPERIMENTAL

RV521

Intervention Type DRUG

RV521 drug in capsules

Placebo

Micro-crystalline cellulose in capsule for oral administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in capsules

Interventions

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RV521

RV521 drug in capsules

Intervention Type DRUG

Placebo

Placebo in capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 to 45 years, inclusive
* In good health with no history of major medical conditions
* A total body weight ≥ 50 kg and a body mass index (BMI) of \>/=18kg/m2 and \</=30kg/m2

Exclusion Criteria

* Evidence of any clinically significant or currently active major medical condition
* Positive for Human Immunodeficiency Virus, active Hepatitis A, B or C test
* Significant nose or nasopharynx abnormalities
* Abnormal lung function
* History or currently active symptoms suggestive of upper or lower respiratory tract infection

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes