Clinical trial NCT03258502: A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-08-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in viral load
timeFrame: Baseline to study day 12
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: hVIVO Services Ltd
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: DeVincenzo J, Tait D, Efthimiou J, Mori J, Kim YI, Thomas E, Wilson L, Harland R, Mathews N, Cockerill S, Powell K, Littler E. A Randomized, Placebo-Controlled, Respiratory Syncytial Virus Human Challenge Study of the Antiviral Efficacy, Safety, and Pharmacokinetics of RV521, an Inhibitor of the RSV-F Protein. Antimicrob Agents Chemother. 2020 Jan 27;64(2):e01884-19. doi: 10.1128/AAC.01884-19. Print 2020 Jan 27.