Conditions: Hemorrhage
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 46
Healthy volunteers: yes

Brief summary:
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

Detailed description:

Arms:
arm 1: Sequential Crossover to Placebo or BI 655075 arm 2: Sequential Crossover to Placebo or BI 655075 arm 3: Sequential Crossover to Placebo or BI 655075 arm 4: Sequential Crossover to Placebo or BI 655075

Interventions: intervention 1: BI 655075 intervention 2: BI 655075 intervention 3: Placebo intervention 4: BI 655075 intervention 5: Placebo intervention 6: Placebo intervention 7: Placebo intervention 8: BI 655075
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None

Protocol document: