NCT04958252已完成1 期
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1569912 in Healthy Male Japanese Subjects (Single-blind, Partially Randomized Within Dose Groups, Placebo-controlled, Parallel-group Design)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Part A and Part B: Percentage of subjects with drug-related adverse events
研究概览
简要总结
The main objectives of this trial are to investigate safety and tolerability of BI 1569912 in healthy male Japanese subjects following oral administration of single rising doses and multiple doses.
Secondary objective is the exploration of pharmacokinetics (PK) of BI 1569912.
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
盲法说明
The single-rising dose part and multiple dose part of the trial are designed single-blind (to participants).
The evening pharmacokinetics part is designed as open-label trial.
入排标准
- 年龄范围
- 18 Years 至 45 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 medical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
- •Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- •Age of 18 to 45 years (inclusive)
- •Body mass index (BMI) of 18.5 to 25.0 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
- •Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
- •Use of adequate contraception, any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
- •Vasectomized (vasectomy at least 1 year prior to enrolment)
- •Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner
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 40 to 90 mmHg, or pulse rate outside the range of 40 to 99 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
- •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.
结局指标
主要结局
Part A and Part B: Percentage of subjects with drug-related adverse events
时间窗: up to 27 days
Part C: Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: up to 3 days
Part C: 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 3 days
次要结局
- Part A: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 4 days)
- Part A: Maximum measured concentration of the analyte in plasma (Cmax)(up to 4 days)
- Part B, after the first dose: Area under the concentration-time curve of the analyte in plasma from 0 to 24 hours (AUC0-24)(up to 17 days)
- Part B, after the first dose: Maximum measured concentration of the analyte in plasma (Cmax)(up to 17 days)
- Part B, after the last dose: Area under the concentration-time curve of the analyte in plasma over the dosing interval τ at steady state (AUCτ,ss)(up to 17 days)
- Part B, after the last dose: Maximum measured concentration of the analyte in plasma at steady state (Cmax,ss)(up to 17 days)
- Part C: Percentage of subjects with drug-related adverse events(up to 3 days)
- Part C: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to 3 days)
研究者
研究点 (2)
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