A Phase I, Open-label Trial in Two Parallel Parts to Investigate Mass Balance, Metabolism, and Basic Pharmacokinetics of BI 3000202 (C-14) Administered as Oral Solution (Part A) and to Investigate Absolute Bioavailability (BA) of BI 3000202 Administered as Film Coated Tablet Together With an Intravenous Microtracer Dose of BI 3000202 (C-14) (Part B) in Healthy Male and Female Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Part A: 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
The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body.
The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion.
Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy.
The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female of non-childbearing potential trial participants 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)
- •Body mass index (BMI) of 18.5 to 30 kg/m² (inclusive)
- •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 (inclusive), diastolic blood pressure outside the range of 50 to 90 mmHg (inclusive), or pulse rate outside the range of 40 to 99 bpm (inclusive)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical significance
- •Any evidence of a concomitant disease assessed as clinically significant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
Part A
Absorption, distribution, metabolism, and excretion (ADME)
干预措施: BI 3000202 (Drug)
Part A
Absorption, distribution, metabolism, and excretion (ADME)
干预措施: BI 3000202 [14C]-labelled (Drug)
Part B
Bioavailability (BA)
干预措施: BI 3000202 (Drug)
Part B
Bioavailability (BA)
干预措施: BI 3000202 [14C]-labelled (Drug)
结局指标
主要结局
Part A: 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 21 days
Part A: 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 21 days
Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity)
时间窗: up to 6 days
次要结局
- Part B: AUC0-tz(up to 6 days)
- Part A: Cmax (maximum measured concentration of the analyte)(up to 20 days)
- Part A: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point)(up to 20 days)
- Part B: Cmax(up to 6 days)