The Effect of Food on the Single-dose Pharmacokinetics of BI 3731579 Administered Orally in Healthy Male Subjects (an Open Label, Two-period, Two-sequence Crossover Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
研究概览
简要总结
This trial investigates whether food influences the amount of BI 3731579 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 50 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 50 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
- •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 Further exclusion criteria apply.
研究组 & 干预措施
BI 3731579 fed - fasted (T-R)
Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
干预措施: BI 3731579 (Drug)
BI 3731579 fasted - fed (R-T)
Treatment R: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h. Treatment T: Healthy male subjects received a single oral dose of BI 3731579 on Day 1 with 240 mL of water, after an overnight fast of at least 10 h followed by a high-calorie, high-fat breakfast. Two single doses (one in each treatment period), separated by a wash-out period of at least 6 days between BI 3731579 drug administrations.
干预措施: BI 3731579 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
Area under the concentration-time curve of BI 3731579 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Maximum Measured Concentration of BI 3731579 in Plasma (Cmax)
时间窗: Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration
Maximum measured concentration of BI 3731579 in plasma (Cmax) is presented.
次要结局
- Area Under the Concentration-time Curve of BI 3731579 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours (hrs) before and 15 minutes (min), 30 min, 1 hrs, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs, 3.5 hrs, 4 hrs, 4.5 hrs, 5 hrs, 6 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs, and 72 hrs after first drug administration)