NCT07211425已完成1 期
The Effect of Multiple Doses of Itraconazole on the Single-dose Pharmacokinetics of BI 3031185 Following Oral Administration in Healthy Trial Participants (an Open-label, Two-period, Fixed- Sequence Design Study)
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
- Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
研究概览
简要总结
The main objective of this trial is to investigate the effect of multiple oral doses of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics of a single dose of BI 3031185 following oral administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 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 (BP), pulse rate (PR)), and 12-lead electrocardiogram (ECG)
- •Age of 18 to 55 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg / m^2 (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
- •Any finding in the medical examination (including BP, Pulse rate (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 of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 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 1584862 (R), then BI 1584862 + itraconazole (T)
Experimental
R=Reference treatment (Period 1) T=Test treatment (Period 2)
干预措施: BI 3031185 (Drug)
BI 1584862 (R), then BI 1584862 + itraconazole (T)
Experimental
R=Reference treatment (Period 1) T=Test treatment (Period 2)
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to Day 13
Maximum measured concentration of BI 3031185 in plasma (Cmax)
时间窗: Up to Day 13
次要结局
- Area under the concentration-time curve of BI 3031185 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to Day 13)
研究者
研究点 (1)
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