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).

Trial Profile

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).

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Feb 2017

At a glance

  • Drugs Idarucizumab (Primary) ; Dabigatran etexilate
  • Indications Blood coagulation disorders
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 23 Feb 2017 Results of pooled analysis (NCT01688830, NCT01955720 and NCT02028780) published in the British Journal of Clinical Pharmacology
    • 06 Dec 2016 Results presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
    • 01 Dec 2016 Results from two phase I studies (NCT01688830 and NCT02028780) assessing markers of pro-coagulant effects in healthy Caucasian and Japanese volunteers were published in the Thrombosis and Haemostasis
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