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A randomized placebo-controlled, Phase 1b pharmacokinetic/pharmacodynamic trial of AM-201 co-administration with olanzapine in healthy volunteers

Trial Profile

A randomized placebo-controlled, Phase 1b pharmacokinetic/pharmacodynamic trial of AM-201 co-administration with olanzapine in healthy volunteers

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 11 Oct 2019

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At a glance

  • Drugs Betahistine (Primary)
  • Indications Somnolence; Weight gain
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Auris Medical
  • Most Recent Events

    • 11 Oct 2019 According to an Auris Medical media release, the study will now proceed to the next higher and final dose level of 30 mg to be tested on 30 healthy volunteers. Data from larger dose cohort are anticipated towards the end of the first quarter of 2020.
    • 11 Oct 2019 Interim Results presented in an Auris Medical Media Release.
    • 15 Aug 2019 According to an Auris Medical media release, the Company expects top-line results from the trial in the coming weeks.
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