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VK4-116 Phase I Study With Food-Effect

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 30, 2026 to Apr 30, 2027 Start date: Nov 1, 2025 to Aug 1, 2026 · Primary endpoint revised · Completion date: Jun 30, 2026 to Aug 30, 2027v3 Show 3 more changesShow less
    • Start date: Nov 1, 2025 to Aug 1, 2026
    • Primary endpoint revised
    • Completion date: Jun 30, 2026 to Aug 30, 2027

    See this version in full on ClinicalTrials.gov ↗

  2. Interventions: VK4-116 (Drug) to Placebo (Drug), VK4-116 (Drug)v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This first-in-human, randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study is designed to assess the safety, tolerability and pharmacokinetics of VK4-116 in healthy volunteers in fasted and fed state.
Trial Details
NCT Number NCT06808932
Lead Sponsor National Institute on Drug Abuse (NIDA)
Collaborators: Altasciences Company Inc.
Conditions Opioid Dependence, Opioid Use Disorder (OUD)
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov