Metabolite Profile, Excretion Balance and Pharmacokinetics of BI 207127 NA Combined With [14C]-BI 207127 NA in Healthy Adult Male Volunteers After an 800 mg Single Oral Solution Dose; a Phase I, Single-arm, Open-label Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC0-infinity of Plasma Deleobuvir
研究概览
简要总结
Phase 1 study to assess the pharmacokinetics and routes of elimination of a single oral dose of [14C]-BI 207127 and to characterize the metabolic profile following single dose administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 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
BI 207127 NA
Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA
干预措施: BI 207127 NA (Drug)
结局指标
主要结局
AUC0-infinity of Plasma Deleobuvir
时间窗: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
Area under the plasma deleobuvir concentration-time curve over the time interval from 0 h extrapolated to infinity (AUC0-infinity)
Cmax of Plasma Deleobuvir
时间窗: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
Maximum measured concentration (Cmax) of plasma deleobuvir
Excretion Balance of Total [14C]-Radioactivity
时间窗: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
Excretion balance of total \[14C\]-radioactivity (urine and faeces)
t1/2 of [14C]-Radioactivity in Plasma
时间窗: 15 minutes (min) before drug administration and 30min, 1 hour (h), 1h 30min, 2h, 2h 30min, 3h, 3h 30min, 4h, 5h, 6h, 8h, 10h, 12h, 15h, 24h, 36h, 48h, 72h and 96h after drug administration
Terminal half life (T1/2) of \[14C\]-radioactivity in plasma
Excretion of Total [14C]-Radioactivity in Urine
时间窗: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
Excretion of total \[14C\]-radioactivity in urine
Excretion of Total [14C]-Radioactivity in Faeces
时间窗: Before drug administration (24hours (h) to 15 minutes pre-dose) and 0h-24h, 24h-48h, 48h-72h, 72h-96h, 96h-120h, 120h-144h, 144h-168h, 168h-192h and 192h-216h after drug administration
Excretion of total \[14C\]-radioactivity in faeces
次要结局
未报告次要终点