Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3731579 in Healthy Volunteers (Single-blind, Randomised, Placebo-controlled, Parallel Group Design)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics and pharmacodynamics of BI 3731579 in healthy volunteers following administration of multiple rising doses per day over 15 days.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers 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), respiratory rate (RR) and temperature), 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 ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including BP, PR, RR, temperature 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 resting pulse rate outside the range of 45 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 Further exclusion criteria apply.
研究组 & 干预措施
Low-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: Low-dose bid BI 3731579 (Drug)
Mid-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: Mid-dose bid BI 3731579 (Drug)
Mid-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single mid-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily mid-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: Midazolam (Drug)
High-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: High-dose bid BI 3731579 (Drug)
Placebo-matching BI 3731579 + midazolam
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579.
干预措施: Placebo-matching BI 3731579 (Drug)
Placebo-matching BI 3731579 + midazolam
Healthy participants took daily placebo-matching film-coated tablets of BI 3731579 on Day 2 and Day 4 to Day 17, orally, with 240 milliliters (mL) of water. On Day 1 and on Day 17, they took 75 micrograms (μg) of midazolam for injection, orally, as a daily single dose, with 240 mL of water. On Day 17, midazolam was taken after placebo-matching BI 3731579.
干预措施: Midazolam (Drug)
Low-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single low-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily low-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: Midazolam (Drug)
High-dose bid BI 3731579 + midazolam
Healthy subjects took, orally, with 240 milliliters (mL) of water, a single high-dose of BI 3731579 on Day 2 and Day 17. From Day 4 to Day 16, they took, orally, with 240 mL of water, a double daily high-dose (bid) of BI 3731579 each day. On Day 1 and Day 17, subjects took additionally 75 micrograms (μg) of midazolam for injection, orally, with 240 mL of water, as a single dose. On Day 17, midazolam was taken after BI 3731579.
干预措施: Midazolam (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: up to Day 27.
Occurrence of Any Treatment-emergent Adverse Event Assessed as Drug-related by the Investigator
时间窗: From first drug administration on Day 2 until last drug administration on Day 17, plus residual effect period (REP) for each intervention. Up to 19 days.
The occurrence of any treatment-emergent adverse event (TEAE) assessed as drug-related by the investigator is reported as number of participants. The primary endpoint was analyzed without the microdose of midazolam on Day 1, as defined in the statistical analysis plan.
次要结局
- AUCτ,ss (area under the concentration-time curve of BI 3731579 in plasma at steady state over a uniform dosing interval τ)(up to Day 19.)
- Cmax,ss (maximum measured concentration of BI 3731579 in plasma at steady state over a uniform dosing interval τ)(up to Day 19.)
- Area Under the Concentration-time Curve of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (AUCτ,ss)(Up to 408 hours. Detailed timeframe in the description.)
- Maximum Measured Concentration of BI 3731579 in Plasma at Steady State Over a Uniform Dosing Interval τ (Cmax,ss)(Up to 408 hours. Detailed timeframe in the description.)