Clinical Trial

VK4-116 Phase I Study With Food-Effect

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-01-29; most recent amendment 2026-04-06.
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 2026-08-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-09