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A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

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Trial Profile

A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 Aug 2018

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At a glance

  • Drugs Aripiprazole lauroxil (Primary)
  • Indications Schizoaffective disorder; Schizophrenia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Alkermes plc

    • Most Recent Events

    • 11 Jun 2018 Outcomes of a PopPK model using data from 4 phase 1 studies including this study (ALK9072-A105) assessing simulations of Aripiprazole for a 1 day initiation regimen for the long acting antipsychotic aripiprazole lauroxil, published in the European Journal of Drug Metabolism and Pharmacokinetics.
    • 06 Jun 2017 According to an Alkermes media release, that the US FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia.
    • 20 Mar 2017 According to an Alkermes media release, a supplemental New Drug Application (sNDA) for the two-month dosing option of ARISTADA is currently under review with the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2017.
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