NCT05469646已完成1 期
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 1819479 in 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
- 24
- 试验地点
- 1
- 主要终点
- Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
This is a study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 1819479 in healthy male Japanese subjects receiving single rising doses (SRD) in order to provide the basis for a clinical development of BI 1819479 in Japan.
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 at screening visit
- •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) at screening visit
- •Body mass index (BMI) of 18.5 to 24.9 kg/m2 (inclusive) at screening visit
- •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
- •Subjects who agree to minimise the risk of making their partner pregnant by fulfilling any of the following criteria starting from the admission to trial site until 90 days after 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.
- •Female partner is postmenopausal, defined as no menses for 1 year without an alternative medical cause.
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 at screening visit
- •Repeated measurement of systolic BP outside the range of 90 to 140 millimetre(s) of mercury (mmHg), diastolic BP outside the range of 40 to 90 mmHg, or PR outside the range of 40 to 99 beats per minute (bpm) at screening visit
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- •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
Dose Group 1: BI 1819479 (Low dose)
Experimental
干预措施: BI 1819479 (Drug)
Dose Group 2: BI 1819479 (Middle dose)
Experimental
干预措施: BI 1819479 (Drug)
Dose Group 3: BI 1819479 (High Dose)
Experimental
干预措施: BI 1819479 (Drug)
Placebo
Placebo Comparator
干预措施: Matching placebo (Drug)
结局指标
主要结局
Percentage of patients treated who experience treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to 64 Days
次要结局
- Area under the concentration-time curve of BI 1819479 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 31 Days)
- Maximum measured concentration of BI 1819479 in plasma (Cmax)(Up to 31 Days)
研究者
研究点 (1)
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