A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 3031185 Administered as Tablet to Healthy Male Subjects, and a Randomised, Open-label, Single-dose, Two-way Cross-over Relative Bioavailability Comparison of BI 3031185 as Tablet With and Without Food in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
研究概览
简要总结
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further development.
The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3031185 tablet formulation.
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
FE part of the trial is designed as open-label. SRD part is designed as blinded to subjects.
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 without any clinically significant abnormalities
- •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 139 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 50 to 89 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
- •Any evidence of a concomitant disease. This does not include acceptable concomitant conditions that were not assessed as clinically relevant by the investigator (e.g. possible cases of myopia, hyperopia, astigmatism, non-active pollinosis, or mild acne of the skin)
- •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: BI 3031185 dose group 4
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 1
Single rising dose (SRD)
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 2
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 3
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 5
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 6
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 7
干预措施: BI 3031185 (Drug)
SRD Part: BI 3031185 dose group 8
干预措施: BI 3031185 (Drug)
SRD Part: Placebo matching BI 3031185
干预措施: Placebo matching BI 3031185 (Drug)
FE part: BI 3031185 under fasted (Reference, R) then BI 3031185 under fed (Test,T) conditions
Food effect (FE)
干预措施: BI 3031185 (Drug)
FE part: BI 3031185 under fed (Test,T) then BI 3031185 under fasted (Reference, R) conditions
干预措施: BI 3031185 (Drug)
结局指标
主要结局
SRD part: The occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
时间窗: Up to 22 days
FE part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)
时间窗: Up to 24 hours
FE part: Maximum measured concentration of the analyte in plasma (Cmax)
时间窗: Up to 8 days
次要结局
- SRD part: Area under the concentration-time curve of the analyte in plasma over the dosing interval 0 to 24 hours (AUC0-24)(Up to 24 hours)
- SRD part: Maximum measured concentration of the analyte in plasma (Cmax)(Up to 13 days)
- FE part: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 8 days)