A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects

Trial Profile

A Phase I, Randomized, Single-Blind, Four-Period Cross-Over, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single Oral Doses of GR181413A/AT1001 in Healthy Japanese Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jun 2017

At a glance

  • Drugs Migalastat (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 28 Jun 2017 According to an Amicus Therapeutics media release, company has submitted a Japanese new drug application (J-NDA) to the Pharmaceuticals and Medical Devices Agency (PMDA) to request marketing authorization for migalastat, an oral precision medicine for Fabry disease, based on data from this study, FACETS and ATTRACT studies.
    • 14 Feb 2017 Results published in an Amicus Therapeutics Media Release
    • 14 Feb 2017 According to an Amicus Therapeutics media release, results from this study are being highlighted at WORLDSymposium 2017.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top