[14C] -RV521.HCl - A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion Following a Single Oral Dose in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Cmax (Maximum observed concentration)
研究概览
简要总结
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:
- Males age 18 to 55 years
- All fertile participants must agree to the use of highly effective contraception
- Body mass index (BMI) of 18 to 32.0 kg/m2; body weight of 55.0 to 100.0 kg.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
200 mg RV521/78 µCi [ 14C]-RV521
200 mg RV521/78 µCi [ 14C]-RV521
干预措施: 200 mg RV521/78 µCi [ 14C]-RV521. (Drug)
结局指标
主要结局
Cmax (Maximum observed concentration)
时间窗: 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-last (AUC from the time of dosing to the time of the last measurable concentration)
时间窗: 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)
时间窗: 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)
时间窗: 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))
时间窗: 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 %))
时间窗: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
Tmax (Time of maximum observed concentration)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
14C associated with % of administered dose of the total in urine and feces
时间窗: Day 1 (time 0) to Day 29
Metabolite Profiling and Identification
CL/F (Apparent clearance of the drug from plasma after oral administration)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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))
时间窗: 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)
时间窗: Day 1 (time 0) to Day 29
Mass balance parameters in urinary and fecal excretion of radioactivity
次要结局
- Spontaneously reported serious AEs (SAEs) during the Treatment Period(Day -1 to Day 29)
- Use of concomitant medications(Day -1 to Day 29)
- Unscheduled assessments as needed for management of AEs(Day -1 to Day 29)
- Blood/Plasma AUC Ratio(Day 1 (time 0 to Day 29))
- 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)
- Amount of 14C excreted into nostrils per sampling interval (in units of mass-equivalents/g)(Day 1 (time 0) to Day 29)
- 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))
- Clinically significant changes from baseline of any of the following: 12-lead electrocardiogram (ECD) assessments(Day -1 to Day 29)
- Clinically significant changes from baseline of any of the following: Physical examinations(Day -1 to Day 29)
- 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)
- Structural identification of major metabolites(Day 1 (time 0) to Day 29)
- Spontaneously reported adverse events (AEs) during the Treatment Period(Day -1 to Day 29)