Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 113608 in Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test
研究概览
简要总结
The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.
A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.
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
- 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 113608 low dose 1
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 medium dose 1
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 high dose 1
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 low dose 2
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 low dose 4
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 low dose 5
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 medium dose 2
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 medium dose 3
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 high dose 2
Powder for oral solution
干预措施: BI 113608 (Drug)
BI 113608 high dose 3
Powder for oral solution
干预措施: BI 113608 (Drug)
Placebo
Powder for oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, Lung Function, Carbon Monoxide Diffusing Capacity of the Lung, ECG, Physical Examination, Orthostasis Test, Oxygen Saturation or Haemoccult Test
时间窗: From administration of study drug until end-of-study visit, up to 10 days
Clinically relevant abnormalities for clinical laboratory evaluation, vital signs, lung function, carbon monoxide Diffusing Capacity Of the Lung (DLCO), Electrocardiogram (ECG), physical examination, orthostasis test, oxygen saturation or haemoccult test
Percentage of Participants With Drug-related Adverse Events
时间窗: From administration of study drug until end-of-study visit, up to 10 days
Percentage of participants with drug-related adverse events
Assessment of Tolerability by the Investigator
时间窗: End of study visit, up to day 10
Assessment of tolerability by the investigator assessed according to the categories good, satisfactory, not satisfactory, bad and not assessable.
次要结局
- AUC0-tz(Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration)
- AUC0-infinity(Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration)
- Tmax(Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration)
- Cmax(Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration)
- t1/2(Before drug administration and 15minutes (min), 30min, 45min, 1hour (h), 1h 30min, 2h, 2h 30min, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 34h, 48h and 72h (for doses >=50mg only) after drug administration)