NCT07774325招募中1 期
The Effects of P-gp Inhibition and OATP Inhibition on the Pharmacokinetics of a Single Oral Dose of BI 3000202 in Healthy Male Trial Participants (an Open-label, Three-period, Two-sequence Crossover Trial, With Period 3 as Fixed Treatment)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve of the analyte in plasma 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 effects of multiple doses of Itraconazole and multiple doses of Ciclosporin on the pharmacokinetics of BI 3000202 in plasma following a single oral dose in healthy male trial participants.
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
- 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, physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body mass index of 18.5 to 29.9 kg/m² (inclusive). Additionally, a minimum body weight of at least 60 kg is required
- •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 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
- •Further exclusion criteria apply.
研究组 & 干预措施
Treatment sequence 1
Experimental
Sequence:
- - Reference treatment (BI 3000202)
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: BI 3000202 (Drug)
Treatment sequence 2
Experimental
Sequence:
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Reference treatment (BI 3000202)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: BI 3000202 (Drug)
Treatment sequence 1
Experimental
Sequence:
- - Reference treatment (BI 3000202)
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: Ciclosporin (Drug)
Treatment sequence 1
Experimental
Sequence:
- - Reference treatment (BI 3000202)
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: Itraconazole (Drug)
Treatment sequence 2
Experimental
Sequence:
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Reference treatment (BI 3000202)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: Ciclosporin (Drug)
Treatment sequence 2
Experimental
Sequence:
- - Test treatment 1 (BI 3000202 + Ciclosporin)
- - Reference treatment (BI 3000202)
- - Test treatment 2 (BI 3000202 + Itraconazole)
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
时间窗: up to 4 days
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 4 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to 4 days)
研究者
研究点 (2)
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