A two-month, multi-center, randomized, double-blind, placebo-controlled hepatic safety study of ubrogepant in healthy volunteers
Phase of Trial: Phase I
Latest Information Update: 25 Oct 2018
At a glance
- Drugs Ubrogepant (Primary)
- Indications Migraine
- Focus Adverse reactions; Registrational
- 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.