A Two-part, Randomised, Single-blind, Placebo-controlled, Single and Multiple Rising Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BI 3776528, Administered to Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
研究概览
简要总结
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
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
Part 1a of this trial is a randomized, single-blind, and placebo-controlled. Part 1b of the trial is randomized, open-label, and with a two-way crossover design.
Part 2 of the trial is single-blind, randomized, and placebo-controlled.
入排标准
- 年龄范围
- 18 Years 至 50 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 and clinical laboratory.
- •Age of 18 to 50 years (inclusive)
- •BMI of 18.5 to 29.9 kg/m² (inclusive), body weight above 60 kg (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement at screening of systolic blood pressure outside the range of 90 to 140 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 (age-adapted) reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin), renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements or abnormal thyroid stimulating hormone (TSH) values outside of the normal range after repeated measurements.
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply.
研究组 & 干预措施
Treatment group
干预措施: short-acting benzodiazepine (Drug)
Placebo group
Applicable for part 1a and part 2 of the trial.
干预措施: Placebo matching BI 3776528 (Drug)
Placebo group
Applicable for part 1a and part 2 of the trial.
干预措施: short-acting benzodiazepine (Drug)
Treatment group
干预措施: BI 3776528 (Drug)
结局指标
主要结局
Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
时间窗: up to 27 days
Part 1a and Part 2: Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to 62 days
Part 1b: AUC0-tz of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)
时间窗: up to 27 days
Part 1b: Cmax of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma)
时间窗: up to 27 days
次要结局
- Part 1a: AUC0-∞ of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 27 days)
- Part 1a: Cmax of BI 3776528 in plasma(up to 27 days)
- Part 1b: AUC0-∞ of BI 3776528 in plasma(up to 27 days)
- Part 2: AUCτ,ss of BI 3776528 in plasma (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)(up to 27 days)
- Part 2: Cmin,ss of BI 3776528 in plasma (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(up to 27 days)
- Part 2: Cmax,ss of BI 3776528 in plasma (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)(up to 27 days)