NCT05520827已完成1 期
A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1584862 Administered as Tablet to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Two-way Crossover Part Investigating Relative Bioavailability of BI 1584862 as Tablet With and Without Food in Healthy Male Subjects (FE Part)
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
- 77
- 试验地点
- 1
- 主要终点
- SRD-part:Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
Single Rising Dose (SRD) part:
The main objectives of the SRD part of this trial are to investigate safety, tolerability, and pharmacokinetics (PK) of BI 1584862 in healthy male subjects following oral administration of single rising doses.
Food Effect (FE) part:
The main objective of the FE part is to assess the influence of food on the relative bioavailability of the BI 1584862 tablet.
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 29.9 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.
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 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm).
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular liver enzymes (AST/ALT) above upper limit of normal and creatinine exceeding 1.2 mg/dl as confirmed by repeat 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
Single Rising Dose part: BI 1584862
Experimental
干预措施: BI 1584862 (Drug)
Single Rising Dose part: Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Food effect part: BI 1584862 fed (treatment test, T)/ BI 1584862 fasted (treatment reference, R)
Experimental
干预措施: BI 1584862 (Drug)
Food effect part: BI 1584862 fasted (treatment reference, R)/ BI 1584862 fed (treatment test, T)
Experimental
干预措施: BI 1584862 (Drug)
结局指标
主要结局
SRD-part:Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to 14 days
FE-part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to 6 days
FE-part: Maximum measured concentration of BI 1584862 in plasma (Cmax)
时间窗: Up to 6 days
次要结局
- SRD-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(Up to 6 days)
- SRD-Part: Maximum measured concentration of BI 1584862 in plasma (Cmax)(Up to 6 days)
- FE-Part: Area under the concentration-time curve of BI 1584862 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 6 days)
研究者
研究点 (1)
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