A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults

Trial Profile

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults

Completed
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
  • Most Recent Events

    • 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.
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