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A Phase I, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers

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A Phase I, Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of INDV-2000 (C4X_3256) Under Fasting and Fed Conditions in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 12 Jun 2024

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At a glance

  • Drugs C4X 3256 (Primary)
  • Indications Opioid-related disorders; Substance-related disorders
  • Focus Adverse reactions; First in man
  • Sponsors Indivior

    • Most Recent Events

    • 10 Jun 2024 According to an Indivior media release, completion of clinical Phase 1 Single 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.
    • 09 Jun 2022 According to an Indivior media release, data from this trial will be presented at the 84th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD), 2022.
    • 14 Apr 2021 Status changed from recruiting to completed.

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