Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The Percentage of Subjects With Drug-related Adverse Events
研究概览
简要总结
To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 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
healthy subjects aged 45-64
Sequential Crossover to Placebo or BI 655075
干预措施: Placebo (Drug)
healthy subjects aged 45-64
Sequential Crossover to Placebo or BI 655075
干预措施: BI 655075 (Drug)
healthy elderly subjects aged 65-80 year
Sequential Crossover to Placebo or BI 655075
干预措施: BI 655075 (Drug)
healthy elderly subjects aged 65-80 year
Sequential Crossover to Placebo or BI 655075
干预措施: Placebo (Drug)
mild renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
干预措施: BI 655075 (Drug)
mild renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
干预措施: Placebo (Drug)
mod renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
干预措施: Placebo (Drug)
mod renal impairment aged 45-80 years
Sequential Crossover to Placebo or BI 655075
干预措施: BI 655075 (Drug)
结局指标
主要结局
The Percentage of Subjects With Drug-related Adverse Events
时间窗: From baseline up to the start of follow-up period (from Day 1 to Day 35)
The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.
Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time
时间窗: End of last infusion and 10 minutes after completion of last infusion of BI 655075
Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.
次要结局
- Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)(from 0 to 6 hours of post Ida dose (details in description))
- AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)(From Day 4 to Day 9 (details in description))
- Cmax (Maximum Measured Concentration of the Ida in Plasma)(From Ida administration to 4 days post dose (details in description))
- AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)(from 2h to12h of post DE dose at steady state (details in description))
- Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)(From 0 to 74h post of last DE dose (details in description))