A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
RV521
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Syncytial Virus Infections
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
Sites / Locations
- hVIVO Services Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RV521
Placebo
Arm Description
RV521 drug substance in capsule for oral administration
Micro-crystalline cellulose in capsule for oral administration
Outcomes
Primary Outcome Measures
Change in viral load
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03258502
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
Aged 18 to 45 years old and will agree to the use of highly effective methods of contraception.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RV521
Arm Type
Experimental
Arm Description
RV521 drug substance in capsule for oral administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Micro-crystalline cellulose in capsule for oral administration
Intervention Type
Drug
Intervention Name(s)
RV521
Intervention Description
RV521 drug in capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in capsules
Primary Outcome Measure Information:
Title
Change in viral load
Time Frame
Baseline to study day 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
hVIVO Services Ltd
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
31712214
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.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=REVC002
Description
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Learn more about this trial
A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
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