A Phase I, Open-label, Single-dose, Single-arm Trial to Investigate Metabolism and Pharmacokinetics of BI 3034701 (C-14) Administered to (Otherwise) Healthy Male Volunteers With Normal Body Weight or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces, 0-tz)
研究概览
简要总结
The main objectives of this trial are:
To assess the mass balance (total recovery of [14C]-radioactivity) in urine, faeces, and expired air after a single subcutaneous dose of BI 3034701 (C-14) in healthy male trial participants.
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 65 Years（Adult, Older 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, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
- •Age of 18 to 65 years (inclusive)
- •Body mass index of 23.0 to 34.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice and local legislation prior to admission to the trial
排除标准
- •Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) 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 50 to 90 beats per minute (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 3034701 (C-14)
干预措施: BI 3034701 (C-14) (Drug)
结局指标
主要结局
Fraction of [14C]-radioactivity excreted in faeces expressed 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 50.
Fraction of [14C]-radioactivity excreted in expired air expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feexpired air, 0-tz)
时间窗: Up to Day 49.
Sum of feurine, 0-tz, fefaeces, 0-tz and feexpired air, 0-tz
时间窗: Up to Day 50.
Fraction of [14C]-radioactivity excreted in urine expressed 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 50.
次要结局
- Area under the concentration-time curve of BI3034701 in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)(Up to Day 22.)
- Maximum measured concentration of [14C]-radioactivity in plasma(Up to Day 22.)
- Maximum measured concentration of BI 3034701 in plasma(Up to Day 22.)
- Area under the concentration-time curve of [14C]-radioactivity in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)(Up to Day 22.)