A Randomised, Single-blind, Placebo-controlled Trial to Investigate Safety, Tolerability, and Pharmacokinetics of Single Rising Doses of BI 1815368 Administered as Oral Solution to Healthy Male Subjects (SRD Part), and a Randomised, Open-label, Single-dose, Three-way Cross-over Part Investigating Relative Bioavailability of BI 1815368 as Tablet Versus Oral Solution and Tablet With and Without Food in Healthy Male Subjects (BA Part)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- SRD part: Occurrence of any treatment-emergent adverse event
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 1815368 in healthy male subjects following oral administration of single rising doses.
Bioavailability (BA) part The main objective of the BA part is to investigate the relative bioavailability of a tablet formulation versus oral solution and to assess the influence of food on the relative bioavailability of the tablet formulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
For the Single Rising Dose (SRD) part the participant is blinded. For the bioavailability (BA) part no masking is applicable.
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 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
- •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: Placebo
干预措施: Placebo (Drug)
SRD part: BI 1815368
干预措施: BI 1815368 formulation 1 (Drug)
BA part: T1-R-T2
R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition
干预措施: BI 1815368 formulation 1 (Drug)
BA part: T1-R-T2
R: BI 1815368 formulation 1, fasted condition T1: BI 1815368 formulation 2, fasted condition T2: BI 1815368 formulation 2, fed condition
干预措施: BI 1815368 formulation 2 (Drug)
BA part: R-T2-T1
干预措施: BI 1815368 formulation 1 (Drug)
BA part: R-T2-T1
干预措施: BI 1815368 formulation 2 (Drug)
BA part: T2-T1-R
干预措施: BI 1815368 formulation 1 (Drug)
BA part: T2-T1-R
干预措施: BI 1815368 formulation 2 (Drug)
结局指标
主要结局
SRD part: Occurrence of any treatment-emergent adverse event
时间窗: Up to Day 14
BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
时间窗: Up to Day 5
BA part: Maximum measured concentration of BI 1815368 in plasma (Cmax)
时间窗: Up to Day 5
次要结局
- SRD part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)(up to Day 6)
- SRD part: Maximum measured concentration of BI 1815368 in plasma (Cmax)(up to Day 6)
- BA part: Area under the concentration-time curve of BI 1815368 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to Day 5)