Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d. for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Drug-related Adverse Events
研究概览
简要总结
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of multiple rising doses of BI 113608 in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 high dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: Placebo to BI 113608 PIB bid (Drug)
BI 113608 high dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: BI 113608 PIB bid (Drug)
BI 113608 low dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: Placebo to BI 113608 PIB bid (Drug)
BI 113608 low dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: BI 113608 PIB bid (Drug)
BI 113608 medium dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: BI 113608 PIB bid (Drug)
BI 113608 medium dose bid
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: Placebo to BI 113608 PIB bid (Drug)
BI 113608 high dose qd
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: Placebo to BI 113608 PIB qd (Drug)
BI 113608 high dose qd
powder in the bottle for oral solution, oral administration with 240 ml water
干预措施: BI 113608 PIB qd (Drug)
结局指标
主要结局
Percentage of Participants With Drug-related Adverse Events
时间窗: From administration of study drug until end-of-study, up to 17 days
Percentage of participants with drug-related adverse events
Number of Participants With Clinically Relevant Abnormalities for Clinical Laboratory Evaluation, Vital Signs, and ECG Recordings
时间窗: From administration of study drug until end-of-study, up to 17 days
Number of participants with Clinically relevant abnormalities for clinical laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), body temperature), and 12- lead electrocardiogram (ECG)
次要结局
- Cmax,ss(311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.)
- Tmax,ss(311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.)
- AUCtau,ss(311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after last dose. The time 324h for the b.i.d treatment and 336h for the q.d. treatment.)
- t1/2,ss(311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h, 360h, 384h after last dose.)
- RA,Cmax(-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.)
- RA,AUC(-2h,0.25h,0.5h,0.75h,1h,1.5h,2h,2.5h,3h,4h,6h,8h,10h,12h,16h,23.917h and 311.917h before dose and 312.25h. 312.5h, 312.75h, 313h, 313.5h, 314h, 314.5h, 315h, 316h, 318h, 320h, 322h, 324h, 328h, 336h after single and multiple dose.)