Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 3000202 in Healthy Male and Female Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design) and Evaluation of Midazolam Interaction in Healthy Male and Female Subjects (Nested, Open, Fixed-sequence, Intra-individual Comparison)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of subjects with drug-related adverse events
研究概览
简要总结
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) following multiple rising doses of BI 3000202 and to investigate the effect of BI 3000202 on the metabolism of midazolam.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The multiple rising dose part of the trial will be blinded to the participants and investigators . The effect of midazolam will be assessed open label.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female of non-childbearing potential 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 55 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
- •Signed and dated written informed consent in accordance with International Conference of Harmonization-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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
Dose group 3
Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: Placebo (Drug)
Dose group 1
Group receiving placebo or dose 1 of BI 3000202
干预措施: BI 3000202 (Drug)
Dose group 1
Group receiving placebo or dose 1 of BI 3000202
干预措施: Placebo (Drug)
Dose group 2
Group receiving placebo or dose 2 of BI 3000202
干预措施: BI 3000202 (Drug)
Dose group 2
Group receiving placebo or dose 2 of BI 3000202
干预措施: Placebo (Drug)
Dose group 3
Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: BI 3000202 (Drug)
Dose group 3
Group receiving midazolam, midazolam and dose 3 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: Midazolam (Drug)
Dose group 4
Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: BI 3000202 (Drug)
Dose group 4
Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: Placebo (Drug)
Dose group 4
Group receiving midazolam, midazolam and dose 4 of BI 3000202 or midazolam and placebo, and only BI 3000202 or only placebo
干预措施: Midazolam (Drug)
结局指标
主要结局
Percentage of subjects with drug-related adverse events
时间窗: Up to day 20
次要结局
- Area under the concentration-time curve of BI 3000202 in plasma over a uniform dosing interval τ (AUCτ,ss) at steady state(Up to day 20)
- Maximum measured concentration of BI 3000202 in plasma (Cmax,ss) at steady state(Up to day 20)
- Time from dosing to the maximum measured concentration of BI 3000202 in plasma (tmax,ss) at steady state(Up to day 20)
- Area under the concentration-time curve of midazolam in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) after a single dose(Up to 2 days)
- Maximum measured concentration of midazolam in plasma (Cmax) after a single dose(Up to 2 days)
- Maximum measured concentration BI 3000202 in plasma (Cmax)(Up to 24 hours)
- Area under the concentration-time curve of BI 3000202 in plasma over the dosing interval 0 to 12 hours (AUC0-12)(Up to 12 hours)