A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT03258502
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Micro-crystalline cellulose in capsule for oral administration RV521 RV521 RV521 drug substance in capsule for oral administration
- Primary Outcome Measures
Name Time Method Change in viral load Baseline to study day 12
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
hVIVO Services Ltd
🇬🇧London, United Kingdom