Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled Parallel Group Design) and Effect of Food on the Relative Bioavailability of BI 1819479 (Open-label, Randomised, Two-way Crossover Design)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Maximum measured concentration of the analyte in plasma (Cmax)
研究概览
简要总结
The main objectives of the single rising doses (SRD) trial part are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1819479 in healthy male subjects following administration of single rising doses.
The main objective of the food effect part is to investigate the influence of food on the relative bioavailability of BI 1819479.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 (BP, PR), 12-lead ECG, and clinical laboratory tests
- •Age of 18 to 50 years (inclusive)
- •BMI of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
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 50 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (ALT/AST) or renal parameters (creatinine) exceeding the ULN after repeated measurements
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •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 1819479
single rising doses (SRD) part
干预措施: BI 1819479 (Drug)
Placebo
Single rising doses (SRD) part
干预措施: Placebo (Drug)
BI 1819479 fed - fasted arm
Food effect part
干预措施: BI 1819479 (Drug)
BI 1819479 fasted - fed arm
Food effect part
干预措施: BI 1819479 (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to Day 31
Food effect part
Percentage of subjects with drug-related adverse events
时间窗: Up to Day 36
Single rising doses (SRD) part
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)
时间窗: Up to Day 31
Food effect part
次要结局
- Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to Day 31)
- Maximum measured concentration of the analyte in plasma (Cmax)(Up to Day 31)
- 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 Day 31)