Effect of Fluconazole on the Pharmacokinetics of a Single Oral Dose of BI 425809 in Healthy Male Subjects (an Open-label, Two-period Fixed-sequence Design Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 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 to 215 hours post administration of BI 425809 (AUC0-215h)
研究概览
简要总结
The main objective of this trial is to investigate the effect of fluconazole, under steady state conditions on the pharmacokinetics of BI 425809 (Reference Treatment R: BI 425809 alone; Test Treatment T: BI 425809 given under steady state conditions of fluconazole).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 Kilograms/Square Meter (kg/m2) (inclusive)
- •Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (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 millimetres 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
- •Relevant 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 425809 (R)/BI 425809 + fluconazole (T)
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R). In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)). There was a washout interval of at least 16 days between the administrations of BI 425809 in the 2 trial periods.
干预措施: BI 425809 (Drug)
BI 425809 (R)/BI 425809 + fluconazole (T)
Participants were administered on Day 1 of treatment period 1 a single oral dose of 1 film-coated tablet of 10 milligram (mg) BI 425809 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) as reference treatment (R). In treatment period 2 participants were administered 400 mg fluconazole as 2 hard capsules of 200 mg once daily (400 mg in total) for 13 days orally with 240 mL of water, starting from Day -4 up to Day 9 of period 2. On Day 1 of period 2 (1 h after the fluconazole administration) a single oral dose of 1 film-coated tablet of 10 mg BI 425809 was administered with 240 mL of water after an overnight fast of at least 10 h (Test Treatment (T)). There was a washout interval of at least 16 days between the administrations of BI 425809 in the 2 trial periods.
干预措施: fluconazole (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 to 215 hours post administration of BI 425809 (AUC0-215h)
时间窗: up to 215 hours
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 215 hours
Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 215 h Post Administration of BI 425809 (AUC0-215)
时间窗: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 215 h post administration of BI 425809 (AUC0-215) is reported.
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
时间窗: Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.
Maximum measured concentration of BI 425809 in plasma (Cmax) is reported.
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 215 hours)
- Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Within 3 hours (h) before and at 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 47h, 71h, 119h, 167h and 215h after administration of BI 425809 on Day 1 of each period.)