Relative Bioavailability of Two Different BI 690517 Formulations as Well as the Effect of Multiple Doses of Probenecid on the Single Dose Pharmacokinetics of BI 690517 Following Oral Administration in Healthy Male and Female Subjects (a Randomised, Open-label, Three-way Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
研究概览
简要总结
This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 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 m accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.
- •Exclusion criteria:
- •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 (beats per minute)
- •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.
排除标准
- 未提供
研究组 & 干预措施
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2
干预措施: BI 690517 formulation 1 (Drug)
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2
干预措施: BI 690517 formulation 2 (Drug)
BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2
干预措施: Probenecid (Drug)
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1
干预措施: BI 690517 formulation 1 (Drug)
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1
干预措施: BI 690517 formulation 2 (Drug)
BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1
干预措施: Probenecid (Drug)
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
干预措施: BI 690517 formulation 1 (Drug)
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
干预措施: BI 690517 formulation 2 (Drug)
Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2
干预措施: Probenecid (Drug)
结局指标
主要结局
AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: Up to day 3.
For the relative bioavailability of BI 690517.
Cmax (maximum measured concentration of BI 690517 in plasma)
时间窗: Up to day 3.
For the drug interaction of BI 690517 with probenecid.
AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)
时间窗: Up to day 3.
For the drug interaction of BI 690517 with probenecid.
次要结局
- AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point)(Up to day 3.)
- AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity)(Up to day 3.)