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
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
- 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.