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NCT05873764 · ClinicalTrials.gov registry record · Phase 1
A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
A Phase 1 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT05873764: Completed Phase 1 study, sponsored by Pfizer.
NCT05873764 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05873764, a Phase 1 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
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.
Primary Outcome
PK parameters of total radioactivity and RV521 following a single oral administration of \[ 14C\]-RV521 to healthy male subjects
Interventions
- DRUG 200 mg RV521/78 µCi [ 14C]-RV521.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2022-07-12 |
| Phase | Phase 1 |
What the finished NCT05873764 record still lists
NCT05873764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which 200 mg RV521/78 µCi [ 14C]-RV521. is the first listed.
NCT05873764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05873764 about?
NCT05873764 is a clinical study titled "A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants". 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 hig...
What is the current status of trial NCT05873764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2022-05-25. Estimated completion is 2022-07-12.
What interventions are being tested in trial NCT05873764?
The interventions under investigation include: 200 mg RV521/78 µCi [ 14C]-RV521. (DRUG).
Who is sponsoring clinical trial NCT05873764?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05873764's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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