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

NCT05873764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Respiratory Syncytial Virus Infections

Interventions

DRUG

200 mg RV521/78 µCi [ 14C]-RV521.

200 mg RV521/78 µCi \[ 14C\]-RV521

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2022-07-12
Completion
2022-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05873764 on ClinicalTrials.gov