Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Intravenous Administration (Part 1) and Investigation of Metabolism and Pharmacokinetics of BI 1265162 (C-14) After Oral Administration (Part 2) in Healthy Male Subjects Following a Non-randomized, Open-label, Single-dose, Single Arm Per Trial Part Mass Balance Design
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Urine
研究概览
简要总结
To investigate rates and routes of excretion, mass balance, pharmacokinetics of parent drug, any known metabolites, and total radioactivity, metabolite profiling, metabolite identification, if suitable assays are available, safety and tolerability in healthy male subjects.
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 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
结局指标
主要结局
Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Urine
时间窗: On Day -1 or Day 1 pre-dose (blank) sample, on Day 1 prior to start of urine collection voiding of the bladder, 0-4 , 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14).
Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
Part 1: Mass Balance Recovery of Total (C-14) BI 1265162-radioactivity in Faeces.
时间窗: On Day -2, Day -1 or Day 1 pre-dose (blank) sample, and on Day 1 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, and 168-192 hours after administration of BI 1265162 (C-14).
Mass balance recovery assessed as amount of (C-14) BI 1265162-radioactivity excreted as a percentage of the single intravenous administered dose of BI 1265162 (C-14) over the time interval from 0 to 192 hours. The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis.
次要结局
- Part 1: Area Under the Concentration-time Curve of Total [14C]BI 1265162-equivalent (EQ) in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)
- Part 1: Area Under the Concentration-time Curve of Total BI 1265162 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)
- Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 Metabolite M582 in Plasma(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)
- Part 1: Percentage of Participants With Drug Related Adverse Events (AEs) Including Clinically Relevant Findings From the Physical Examination(From drug administration up to 22 days.)
- Part 1: Area Under the Concentration-time Curve of Total BI 1265162 Metabolite M582 in Plasma Over the Time Interval From 0 to 192 Hours (the Last Quantifiable Data Point (AUC0-tz))(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)
- Part 1: Maximum Measured Concentration (Cmax) of Total [14C]BI 1265162-equivalent (EQ) in Plasma(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)
- Part 1: Maximum Measured Concentration (Cmax) of Total BI 1265162 in Plasma(At 02:00 hours:minutes pre-dose and at 0:05, 00:30, 00:59 01:05, 01:10, 01:40, 02:00, 03:00, 04:00, 05:00, 07:00, 08:00, 09:00, 11:00, 12:00, 24:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 after single dose of BI 1265162 (C-14).)