A Phase 1 Study To Evaluate The Metabolism And Excretion Of [14C] PF-00868554 In Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The amount of radioactivity recovered in urine and feces, as a percent of the dose.
研究概览
简要总结
This is a phase 1 study to assess the routes of elimination of a single oral dose of [14C] PF-00868554 and to characterize the metabolic profile following single dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, healthy volunteers.
排除标准
- 未提供
研究组 & 干预措施
1
[14C]-PF-00868554
干预措施: [14C]-PF-00868554 (Drug)
结局指标
主要结局
The amount of radioactivity recovered in urine and feces, as a percent of the dose.
时间窗: 7 weeks
The amount of PF-00868554, expressed as a percent of total radioactivity, in plasma, urine, and feces.
时间窗: 7 weeks
Identification and determination of relative abundance of the metabolites of PF-00868554 in plasma, urine, and feces.
时间窗: 7 weeks
PK parameters: AUClast, AUCinf, maximum concentration (Cmax), time of maximum concentration (Tmax), and half-life (t1/2) to describe the single dose PK of a) total radioactivity in blood; b) total radioactivity in plasma; c) PF-00868554 in plasma.
时间窗: 7 weeks
次要结局
- Safety endpoints including adverse events, clinical laboratory tests, vital signs and ECGs.(7 weeks)