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A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder

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Trial Profile

A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder

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

Latest Information Update: 12 Jun 2024

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At a glance

  • Drugs Buprenorphine/naloxone (Primary) ; C4X 3256 (Primary)
  • Indications Opioid-related disorders
  • Focus Adverse reactions
  • Sponsors Indivior
  • Most Recent Events

    • 10 Jun 2024 According to an Indivior media release, completion of clinical Phase 1 Multiple Ascending Dose study happened after an end-of-Phase 1 meeting with the FDA on November 3, 2023, paving the way for the preparation and initiation of this clinical Phase 2 proof-of-concept (PoC) study.
    • 01 Aug 2023 According to a C4X Discovery media release, the Phase 1 multiple ascending dose (MAD) study is currently ongoing.
    • 18 Jul 2023 Status changed from active, no longer recruiting to completed.
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