Randomized, Placebo-controlled, Double-blind Within Dose Groups, Multiple Rising-dose Study to Evaluate Safety, Tolerability, and PK of Oral BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With COPD Associated With Chronic Bronchitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number (%) of Patients With Drug-related Adverse Events (AEs)
研究概览
简要总结
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: Placebo to BI 113608 low dose b.i.d. (Drug)
BI 113608 low dose b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: BI 113608 low dose b.i.d. (Drug)
BI 113608 medium dose b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: Placebo to BI 113608 medium dose b.i.d. (Drug)
BI 113608 medium dose b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: BI 113608 medium dose b.i.d. (Drug)
BI 113608 high dose b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: Placebo to BI 113608 high dose b.i.d. (Drug)
BI 113608 high dose b.i.d.
Film-coated tablet, oral administration with 240 mL water
干预措施: BI 113608 high dose b.i.d. (Drug)
结局指标
主要结局
Number (%) of Patients With Drug-related Adverse Events (AEs)
时间窗: AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)
Number (%) of patients with drug-related adverse events (AEs)
次要结局
- Cmax,ss(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)
- Tmax,ss(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)
- T1/2,ss(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)
- AUC Tau,ss(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)
- R(A,Cmax)(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)
- R(A,AUC)(Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration)