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A Phase 1 Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

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A Phase 1 Randomized, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASP8062 With a Single Dose of Morphine in Recreational Opioid Using Participants

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2021

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At a glance

  • Drugs ASP 8062 (Primary) ; Morphine
  • Indications Opioid-related disorders
  • Focus Adverse reactions
  • Sponsors Astellas Pharma Global Development

    • Most Recent Events

    • 13 Oct 2020 Status changed from recruiting to completed.
    • 22 Jul 2020 According to an Astellas Pharma media release, formal approval and funding from NIDA for the phase 1 clinical study program was granted following the opening of an Investigational New Drug (IND) application by the FDA for ASP8062 in OUD in April 2020.
    • 22 Jul 2020 According to an Astellas Pharma media release, the company has been awarded a grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH) in the U.S. to fund this study.

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