NCT05515588已完成1 期
A Phase I, Open-label Trial to Investigate Metabolism, Pharmacokinetics (Following a Mass Balance Design) and Absolute Bioavailability of BI 690517 (C-14) After Oral and Intravenous Administration in Healthy Male Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz )
研究概览
简要总结
The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.
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
- 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 subjects 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 29.9 kg/m2 (inclusive).
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.
排除标准
- •Subjects will not be allowed to participate, if any of the following general criteria apply:
- •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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 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.
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair).
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.
- •History of relevant orthostatic hypotension (including but not limited to a reduction in systolic BP of ≥20 mm Hg or in diastolic BP of ≥10 mm Hg within 3 minutes of standing during screening measurement associated with clinical symptoms), fainting spells, or blackouts.
- •Further exclusion criteria apply.
研究组 & 干预措施
Part A: BI 690517 (C-14)
Experimental
干预措施: BI 690517 (C-14) (Drug)
Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R)
Experimental
干预措施: BI 690517 (C-14) (Drug)
Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R)
Experimental
干预措施: BI 690517 (Drug)
结局指标
主要结局
Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz )
时间窗: Up to 22 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞)
时间窗: Up to 3 days.
Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞)
时间窗: Up to 3 days.
Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz)
时间窗: Up to 22 days.
次要结局
- Part B: Maximum measured concentration of the analyte in plasma (Cmax)(Up to 3 days.)
- Part A: Maximum measured concentration of the analyte in plasma (Cmax)(Up to 8 days.)
- Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)(Up to 8 days.)
- Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz)(Up to 3 days.)
研究者
研究点 (1)
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