Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201, United States
NCT Number: NCT05873764
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.
Looking for future studies?
Notify Me18 year–55 year
Male
Interventional
Phase 1
Baltimore, Maryland, 21201, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(key):
Exclusion criteria
(key):
200 mg RV521/78 µCi [ 14C]-RV521
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Time frame: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Time frame: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
Time frame: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
Time frame: Day -1 to Day 29
safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day -1 to Day 29
Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Time frame: Day 1 (time 0 to Day 29)
AUC0-inf of total 14C in whole blood divided by the AUC0-inf of total 14C in plasma
Time frame: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
Time frame: Day 1 (time 0 to Day 29)
Metabolite Profiling and Identification
Time frame: Day 1 (time 0) to Day 29
PK parameters of total radioactivity and RV521 following a single oral administration of [ 14C]-RV521 to healthy male subjects
Time frame: Day 1 (time 0) to Day 29
Identification of each metabolite that accounts for ≥10% of circulating radiolabel
Pfizer
Industry
[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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