A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers

Trial Profile

A Randomized, Double-Blind, Vehicle-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibitors in Healthy Volunteers

Completed
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2016

At a glance

  • Drugs Andexanet alfa (Primary)
  • Indications Haemorrhage
  • Focus Pharmacodynamics; Proof of concept; Registrational
  • Sponsors Portola Pharmaceuticals
  • Most Recent Events

    • 19 Feb 2016 Pooled analysis (n=298) of 3 trials, including this and 2 other studies [ANNEXA-A and ANNEXA-R] were presented at the 41st International Stroke Conference.
    • 30 Sep 2015 Status changed from recruiting to completed as reported by ClinicalTraisl.gov record.
    • 06 Aug 2014 According to a Portola Pharmaceuticals media release, proof-of-concept data with edoxaban are anticipated in 2014.
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