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

Trial Profile

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

Planning
Phase of Trial: Phase I

Latest Information Update: 15 Jan 2019

At a glance

  • Drugs Betahistine (Primary) ; Olanzapine
  • Indications Weight gain
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Proof of concept
  • Most Recent Events

    • 15 Jan 2019 According to an Auris Medical media release, clinical trial application has been submitted and the company expects to start recruitment in this trial in first quarter of 2019.
    • 20 Nov 2018 According to an Auris Medical media release, following the read-out from the study, the Company expects to file the IND application for AM-201 later in 2019.
    • 17 Oct 2018 According to an Auris Medical media release, the trial is expected to start in the first quarter of 2019.
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