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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: RV521; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03258502

C5241002 (Other Identifier)

REVC002

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups, including a placebo group

RV521

Experimental group

Description:

RV521 drug substance in capsule for oral administration

Treatment:

Drug: RV521

Placebo

Placebo Comparator group

Description:

Micro-crystalline cellulose in capsule for oral administration

Treatment:

Drug: Placebo