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A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants

[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects

NCT05873764•Pfizer

View on ClinicalTrials.gov

Summary

The purpose of this clinical trial is to learn about the safety, effects, and tolerability of the study medicine (sisunatovir). This study is looking for healthy adult participants who meet the following criteria: 1. Males age 18 to 55 years 2. All fertile participants must agree to the use of highly effective contraception 3. Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg. 4. Participants who are overtly healthy as determined by medical evaluation. This includes medical history, physical examination, blood pressure, pulse rate, standard 12-lead ECG (electrocardiogram), and laboratory tests. This study will enroll up to 10 participants. All study participants will receive 1 dose of sisunatovir by mouth. The study duration is expected to be about 9 weeks. This includes a 28-day screening period, 16-day inpatient stay, and 2 overnight follow-up visits, if needed.

Eligibility

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Males
•Age 18- 55 years
•Body mass index (BMI) 18.0 kg/m2 to 32.0 kg/m2
•Body weight 55.0 kg to 100.0 kg
•Considered to be in good health
•Nonsmoker
•Content of 14C in urine, whole blood, and/or plasma samples does not exceed the general environmental background level of 14C

Exclusion Criteria

•Clinically significant abnormal medical history or any abnormal finding on physical examination, vital signs, ECG, laboratory tests
•History of cancer that has not been in full remission for \>5 years
•Acute illness within 14 days prior to Day 1
•History of significant drug allergies
•History or presence of alcohol or drug abuse
•Recent history of incomplete bladder emptying with voiding or awakening more than once at night to void
•Usual habit of \<1 or \>3 bowel movements per day
•Exposure to radiation for therapeutic, diagnostic, or occupational reasons within the 12 months prior to Day 1.
•Participation in another clinical study in which a \[14C\]-labeled drug was administered within 1 year prior to Check-in
•Administration of another investigational medication within 60 days (or 5 half-lives, whichever is longer) prior to Day 1
+11 more criteria

Locations (1)

Pharmaron Clinical Pharmacology Center

Baltimore, Maryland, United States

Key Dates

Start Date

May 25, 2022

Primary Completion Date

July 12, 2022

Completion Date

July 12, 2022

Last Updated

May 16, 2024

Enrollment

ACTUAL participants

Conditions

Respiratory Syncytial Virus Infections

Interventions

200 mg RV521/78 µCi [ 14C]-RV521.

DRUG

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

NCT07220109

Respiratory Syncytial Virus Infections

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RECRUITINGPHASE2

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865

Respiratory Syncytial Virus Infections

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants

Inclusion Criteria

Exclusion Criteria

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

Genotype and Disease Burden of RSV in Older Vietnamese Adults (RSV: Respiratory Syncytial Virus )

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

Safety and Immunogenicity of CodaVax-RSV in Seropositive and Seronegative Children

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset