Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
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.
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of
5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled
bleeding or require emergency surgery or procedures.
Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Not yet recruiting
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with
very high affinity. Idarucizumab potently and specifically binds to dabigatran and its
metabolites and neutralises its anticoagulant effect. A clinical development program is
ongoing to support marketing authorisation submissions for idarucizumab indicated in
patients treated with dabigatran who require emergency surgery/urgent procedures or who have
a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects
of dabigatran is required.
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