A Study to Learn About Effect of Sisunatovir in Healthy Adult Male Participants
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Drug: 200 mg RV521/78 µCi [ 14C]-RV521.
- Registration Number
- NCT05873764
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 200 mg RV521/78 µCi [ 14C]-RV521 200 mg RV521/78 µCi [ 14C]-RV521. 200 mg RV521/78 µCi \[ 14C\]-RV521
- Primary Outcome Measures
Name Time Method AUC0-last (AUC from the time of dosing to the time of the last measurable concentration) 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
lambdaz (Rate constant associated with the terminal elimination phase) 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
Cmax (Maximum observed concentration) 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
Ae0-t (cumulative amount of 14C excreted into urine from time 0 to the last sampling interval) 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
Ae0-t (Cumulative amount of 14C excreted into urine and feces from time 0 to the last sampling interval (in units of mass-equivalents/g)) Day 1 (time 0) to Day 29 Mass balance parameters in urinary and fecal excretion of radioactivity
Fet (Fraction of 14C excreted into urine and feces per sampling interval (in units of %)) Day 1 (time 0) to Day 29 Mass balance parameters in urinary and fecal excretion of radioactivity
Tmax (Time of maximum observed concentration) 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
AUC0-inf (Area under the concentration-time curve (AUC) extrapolated to infinity) 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
Fe (fraction of administered drug excreted into urine) 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
14C associated with % of AUC of the total in plasma Day 1 (time 0) to Day 29 Metabolite Profiling and Identification
14C associated with % of administered dose of the total in urine and feces Day 1 (time 0) to Day 29 Metabolite Profiling and Identification
CL/F (Apparent clearance of the drug from plasma after oral administration) 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
Vz/F (Volume of distribution associated with the terminal phase) 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
CLR (renal clearance) 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
t1/2 (half-life of the terminal elimination phase) 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
Aet (Amount of 14C excreted into urine and feces per sampling interval (in units of mass-equivalents/g)) Day 1 (time 0) to Day 29 Mass balance parameters in urinary and fecal excretion of radioactivity
Fe0-t (Cumulative fraction of 14C excreted into urine or feces from time 0) Day 1 (time 0) to Day 29 Mass balance parameters in urinary and fecal excretion of radioactivity
- Secondary Outcome Measures
Name Time Method Use of concomitant medications Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Spontaneously reported serious AEs (SAEs) during the Treatment Period Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Unscheduled assessments as needed for management of AEs Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Blood/Plasma AUC Ratio 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
Clinically significant changes from baseline of any of the following: Vital Signs (blood pressure, heart rate [HR], respiratory rate [RR], and oral temperature) Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g) Day 1 (time 0) to Day 29 Metabolite Profiling and Identification
Cumulative amount of 14C excreted into nostrils, urine, and feces from time 0 to the last sampling interval (in units of mass-equivalents/g) Day 1 (time 0 to Day 29) Metabolite Profiling and Identification
Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Clinically significant changes from baseline of any of the following: Physical examinations Day -1 to Day 29 Safety and tolerability of a single oral dose of RV521 in healthy male subjects
Evaluation of total radioactivity in nasal samples following a single oral administration of [ 14C]-RV521 to healthy male subjects 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
Structural identification of major metabolites Day 1 (time 0) to Day 29 Identification of each metabolite that accounts for ≥10% of circulating radiolabel
Spontaneously reported adverse events (AEs) during the Treatment Period Day -1 to Day 29 safety and tolerability of a single oral dose of RV521 in healthy male subjects
Trial Locations
- Locations (1)
Pharmaron Clinical Pharmacology Center
🇺🇸Baltimore, Maryland, United States