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Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)

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Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 02 Mar 2017

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At a glance

  • Drugs Idarucizumab (Primary)
  • Indications Blood coagulation disorders
  • Focus Adverse reactions; First in man; Proof of concept; Registrational
  • 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
    • 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
    • 15 Aug 2015 Results for Part 2 (reversal of the anticoagulant effect of dabigatran etexilate) published in the Lancet.

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