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A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers

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Trial Profile

A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 25 Oct 2018

At a glance

  • Drugs Ubrogepant (Primary)
  • Indications Migraine
  • Focus Adverse reactions; Registrational

    • Most Recent Events

    • 25 Oct 2018 New trial record
    • 17 Oct 2018 According to an Allergan media release, based on the completion of this safety study and results from the ACHIEVE I (UBR-MD-01) and ACHIEVE II (UBR-MD-02) studies, the company will submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the first quarter of 2019.
    • 17 Oct 2018 According to an Allergan media release, this study was conducted based on FDA recommendations to complete a hepatic safety study.
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