Non-randomised, Open Label, Sequential-group Study to Assess the Pharmacokinetics and Pharmacodynamic Effect of Different Multiple Oral Doses of BI 425809 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
研究概览
简要总结
To assess the exposure of BI 425809 in cerebrospinal fluid relative to plasma as well as safety and tolerability, and to evaluate the effect of different doses of BI 425809 on biomarkers levels in cerebrospinal fluid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), puls rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (incl.)
- •Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
- •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), puls rate (PR) or electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range and considered as clinical relevant by investigator
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease judged as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders Further exclusion criteria may apply
研究组 & 干预措施
BI 425809 25 mg
Participants administered BI 425809 25 mg tablet (1x25 mg) once daily in the morning for 14 days.
干预措施: BI 425809 (Drug)
BI 425809 50 mg
Participants administered BI 425809 50 mg tablet (2x25 mg) once daily in the morning for 14 days.
干预措施: BI 425809 (Drug)
BI 425809 10 mg
Participants administered BI 425809 10 mg tablet (2x5 mg) once daily in the morning for 14 days.
干预措施: BI 425809 (Drug)
BI 425809 5 mg
Participants administered BI 425809 5mg tablet (1x5 mg) once daily in the morning for 14 days.
干预措施: BI 425809 (Drug)
结局指标
主要结局
Maximum Measured Concentration of BI 425809 in Plasma (Cmax)
时间窗: 10 minutes pre-dose, up to 384:00h after first administration of BI 425809 (for detailed timeframe please see description).
Maximum measured concentration of BI 425809 in plasma is reported. Time Frame: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h, 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h, 312:00h and 312:30h, 313:00h, 314:00h, 315:00h, 315:30h, 316:00h, 316:30h, 317:00h, 318:00h, 320:00h, 322:00h, 324:00h, 336:00h, 360:00h, 384:00h after first administration of BI 425809.
Area Under the Concentration-time Curve of BI 425809 in Plasma Over the Time Interval From 0 to 14h (AUC0-14)
时间窗: 0:10 hours (h) pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to 14h (AUC0-14).
Area Under the Concentration-time Curve of BI 425809 in CSF Over the Time Interval From 0 to 14h (AUC0-14)
时间窗: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h after first administration of BI 425809.
Area under the concentration-time curve of BI 425809 in cerebrospinal fluid (CSF) over the time interval from 0 to 14h (AUC0-14).
Maximum Measured Concentration of BI 425809 in CSF (Cmax)
时间窗: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Maximum measured concentration of BI 425809 in CSF is reported.
Concentration of BI 425809 in Plasma at the Time Point 312h (C312)
时间窗: 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 3:30h, 4:00h, 4:30h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, and 14:00h and 24:00h, 48:00h, 72:00h, 120:00h, 168:00h, 216:00h, 264:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in plasma at the time point 312h (C312) is reported.
Concentration of BI 425809 in CSF at the Time Point 312h (C312)
时间窗: 1:30h, 1:00h and 0:10h pre-dose and 0:30h, 1:00h, 2:00h, 3:00h, 4:00h, 5:00h, 6:00h, 8:00h, 10:00h, 12:00h, 14:00h and 312:00h after first administration of BI 425809.
Concentration of BI 425809 in CSF at the time point 312h (C312) is reported.
次要结局
- Percentage of Participants With Drug-related Adverse Events (AEs)(From the first drug administration until 11 days after the last drug administration, up to 30days.)