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

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Pharmacokinetics And Antiviral Activity Of Multiple Doses Of RV521 Against Respiratory Syncytial Virus Infection In The Virus Challenge Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03258502
• Other study ID #: REVC002
• Secondary ID: 2017-001282-24
• Status: Completed
• Phase: Phase 2
• Start date: July 19, 2017
• Est. completion date: October 31, 2017

Study information

• Verified date: July 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• RV521
RV521 drug in capsules
• Placebo
Placebo in capsules

Locations

Country	Name	City	State
United Kingdom	hVIVO Services Ltd	London

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load		Baseline to study day 12

External Links

•   To obtain contact information for a study center near you, click here.