NCT06494774已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Oral Doses and Multiple Oral Doses Over 10 Days of BI 1815368 in Japanese Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability. pharmacokinetics (PK), and pharmacodynamics of BI 1815368 in healthy Japanese male subjects following administration of single rising doses or multiple doses.
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 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 physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12- lead Electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 45 years (inclusive)
- •Body mass index (BMI) of 18.5 to 25 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
- •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
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 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 40 to 90 mmHg, or pulse rate outside the range of 40 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
- •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
SRD part: low dose
Experimental
Single-rising dose (SRD)
干预措施: BI 1815368 (Drug)
SRD part: medium dose followed by MD part
Experimental
Single-rising dose (SRD) Multiple dose (MD)
干预措施: BI 1815368 (Drug)
SRD part: high dose
Experimental
干预措施: BI 1815368 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo matching BI 1815368 (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to 26 days
次要结局
- SRD part: Maximum measured concentration of the analyte in plasma (Cmax)(Up to 6 days)
- SRD part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 6 days)
- MD part: Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)(Up to 19 days)
- MD part: Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmin,ss)(Up to 19 days)
- MD part: Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)(Up to 19 days)
研究者
研究点 (1)
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