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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 is a Phase 1 study that has completed, run by Pfizer. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05873764
The ClinicalTrials.gov registry entry for NCT05873764 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 200 mg RV521/78 µCi [ 14C]-RV521. is the first listed.
NCT05873764 reports 0 study locations.
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.
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