Randomised, Double-blind Within Dose Groups, Placebo-controlled Phase I Trial in Healthy Japanese Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Different Doses of BI 655075 (Part 1) and to Explore the Effective Dose of BI 655075 to Reverse Dabigatran Anticoagulant Activity (Part 2).
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
- Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
研究概览
简要总结
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of dabigatran.
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
- 20 Years 至 45 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
Idarucizumab single doses
different infusion durations
干预措施: Placebo to dose (Drug)
Idarucizumab single doses
different infusion durations
干预措施: Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
干预措施: Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
干预措施: Placebo to Idarucizumab (Drug)
Idarucizumab with dabigatran
short infusion with 2 capsules dabigatran
干预措施: dabigatran (Drug)
结局指标
主要结局
Percentage of Subjects With Drug-related Adverse Events in Part 1 and Part 2
时间窗: From first drug administration until 13 weeks after the last drug administration, upto 98 days (Part-I) & upto 108 days (Part-II)
Percentage of subjects with drug-related adverse events in Part 1 and Part 2.
次要结局
- Ae0-74,ss on Days 4 and 11 for Sum Dabigatran (Part II)(0-2 h, 2-6 h, 6-10 h, 10-12 h,12-14h, 14-26 h, 26-50 h, 50-74 h after drug administration of dabigatran etexilate on Day 4 and Day 11.)
- Cmax for Idarucizumab in the Part I & Part II.(Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section)
- AUC0-inf for Idarucizumab in the Part I & Part II.(Day 1 to 3 (Part I) and Day 11 to 13 (Part II); Time frame are provided in detail in the Description section)
- AUC2-12,ss on Days 4 and 11 for Unbound Sum Dabigatran (Part II).(Day 4 (Part I) and Day 11 (Part II). Time frame are provided in detail in the Description section)
- AUEC2-12(Day 4 and Day 11 (Part II); Time frame are provided in detail in the Description section)
- Ae0-73 for the Dose Group 4 in the Part I(For dose group 4 (day1 to day4-Part-1): 0-7h, 7-13h, 13-25h, 25-49h, 49-73h)
- Ae0-72 for Idarucizumab in the Part I & Part II.(Day 1 to 4 (Part I) and Day 11 to 14 (Part II); Time frame are provided in detail in the Description section)