NCT02722161已完成1 期
A Phase I, Open-label, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of [14C]BI 1482694 Administered as Oral Solution in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Mass balance recovery of [14C]-radioactivity in urine: fe urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
研究概览
简要总结
To investigate the basic pharmacokinetics of BI 1482694, its metabolites M1 and M2, and [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C]BI 1482694 given to healthy male volunteers
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
- 45 Years 至 65 Years（Adult, Older 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
[14C]BI 1482694
Experimental
干预措施: [14C]BI 1482694 (Drug)
结局指标
主要结局
Mass balance recovery of [14C]-radioactivity in urine: fe urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
时间窗: up to 1181 hours (7 weeks)
Mass balance recovery of [14C]-radioactivity in faeces: fe faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point)
时间窗: up to 1181 hours (7 weeks)
次要结局
- AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) for BI 1482694 in plasma(up to 72 hours)
- AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) for [14C]-radioactivity in plasma(up to 336 hours)
- Cmax (maximum measured concentration of the analyte) for [14C]-radioactivity in plasma(up to 336 hours)
- Cmax (maximum measured concentration of the analyte) for BI 1482694 in plasma(up to 72 hours)
研究者
研究点 (1)
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