A Human Absorption, Distribution, Metabolism and Excretion (hADME) and Absolute Bioavailability Trial After a Single Micro-tracer Dose of BI 1584862 (C-14) and a Single, Concomitant, Intravenous Micro-dose of BI 1584862 (C-13) in Healthy Male Trial Participants (a Phase I, Open-label, Non-randomised, Single-dose, Fixed-sequence Trial)
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
- Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)
研究概览
简要总结
The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
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
- •Healthy male trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive) at screening
- •BMI of 18.5 to 29.9 kg / m2 (inclusive) at screening
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment)
干预措施: [13C]-labeled BI 1584862 (Drug)
BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment)
干预措施: Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 (Drug)
结局指标
主要结局
Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)
时间窗: Up to Day 14
hADME part
Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)
时间窗: Up to Day 14
hADME part
Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity)
时间窗: Up to Day 14
hADME part
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞)
时间窗: Up to day 13
BA part
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞)
时间窗: Up to Day 6
BA part
次要结局
- AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)(Up to Day 6)
- Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)(Up to Day 13)
- Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)(Up to Day 13)
- AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14)(Up to Day 13)
- AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14)(Up to Day 13)
- Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13)(Up to Day 6)