A Randomised, Double-blind, Placebo-controlled (Within Dose Groups) Phase I Study to a) Assess Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of 2 mg to 350 mg of BI 661051 Administered as Oral Drinking Solution (Powder in Bottle) in Healthy Male Volunteers, b) to Explore the Relative Oral Bioavailability of a Tablet Formulation and c) to Assess the Impact of a High Fat Meal on the Oral Bioavailability of the Oral Drinking Solution (Powder in Bottle)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Orthostasis test parameters
研究概览
简要总结
The objective of the current study is to investigate safety, tolerability, and pharmacokinetics of treatment with BI 661051 rising single doses administered as oral drinking solution (powder in bottle) in healthy male subjects.
The primary objective is to investigate the safety and tolerability of treatment with BI 661051.
The secondary objectives are (1) to evaluate the single dose pharmacokinetics of BI 661051, (2) to explore dose proportionality, (3) to explore the relative bioavailability when BI 661051 is administered as tablet at two dose levels compared to oral drinking solution and (4) to assess the effect on the bioavailability when BI 661051 is administered as oral drinking solution after intake of a high fat meal.
Pharmacodynamic parameters will not be determined within this study.
详细描述
Purpose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BI 661051 high dose, medium
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 low dose, low
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 low dose, medium
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 high dose, low
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 low dose, high
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 medium dose, low
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 medium dose, medium
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 medium dose, high
solution for oral administration, single dose
干预措施: BI 661051 (Drug)
BI 661051 low dose
tablet
干预措施: BI 661051 (Drug)
BI 661051 medium dose
tablet
干预措施: BI 661051 (Drug)
Placebo
solution for oral administratrion
干预措施: Placebo (Drug)
结局指标
主要结局
Orthostasis test parameters
时间窗: 14 weeks
Body temperature
时间窗: 14 weeks
Occurrence of findings of physical examination
时间窗: 14 weeks
Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate [RR])
时间窗: 14 weeks
Clinical laboratory test parameters (haematology, clinical chemistry and urinalysis parameters)
时间窗: 14 weeks
Occurrence of findings detected by the pupillometry measurements
时间窗: 14 weeks
Tolerability assessed by investigator
时间窗: 14 weeks
12-lead electrocardiogram (ECG) parameters (heart rate, PQ interval, QRS interval, uncorrected QT interval as well as Bazett- and Fridericia corrected QT interval)
时间窗: 14 weeks
Occurrence of adverse events (AEs) on the level of Medical Dictionary for Regulatory Affairs (MedDRA) Preferred Terms and MedDRA System Organ Class
时间窗: 14 weeks
次要结局
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration)(14 weeks)
- AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(14 weeks)
- Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2)(14 weeks)
- Cmax (maximum measured concentration of the analyte in plasma)(14 weeks)