A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
Phase of Trial: Phase I
Latest Information Update: 29 Oct 2015
At a glance
- Drugs ALKS 8700 (Primary) ; Dimethyl fumarate
- Indications Multiple sclerosis
- Focus Adverse reactions
- Sponsors Alkermes plc
- 29 Oct 2015 Based on a meeting with the US FDA, Alkermes plans to file a 505(b)(2) NDA using pharmacokinetic bridging data from this trial and a two-year phase III safety study (see CT profile 700253825) and this trial. The company expects to file the NDA in 2018.
- 29 Oct 2015 Results published in an ALkermes media release.
- 29 May 2015 Results published in the Alkermes Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History