NCT06166992已完成1 期
Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 1291583 Administered as an Oral Dose With an Intravenous Microtracer Dose of [14C]-BI 1291583 in Healthy Male Volunteers
适应症
干预措施
相关药物
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
- Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)
研究概览
简要总结
The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).
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
- 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 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
- •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, fainting spells, or blackouts Further exclusion criteria apply.
研究组 & 干预措施
BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)
Experimental
干预措施: BI 1291583 (Drug)
BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled)
Experimental
干预措施: [14C]-BI 1291583 (Drug)
BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)
Experimental
干预措施: BI 1291583 (Drug)
BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled)
Experimental
干预措施: [14C]-BI 1291583 (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: Up to 10 days
次要结局
- Maximum measured concentration of the analyte in plasma (Cmax)(Up to 10 days)
- 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 10 days)
研究者
研究点 (1)
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