VK4-116 for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
Yes, you will need to stop taking prescribed medications 14 days before the study and over-the-counter medications, supplements, or vitamins 7 days before the study.
Is VK4-116 safe for humans?
How does the drug VK4-116 differ from other treatments for opioid use disorder?
VK4-116 is unique because it targets dopamine D3 receptors, which are involved in the brain's reward system, to reduce opioid cravings and prevent relapse without affecting pain relief. This is different from standard treatments like methadone and buprenorphine, which primarily target opioid receptors.25678
Who Is on the Research Team?
Marta De Santis, PhD
Principal Investigator
National Institute on Drug Abuse, NIH
Are You a Good Fit for This Trial?
This trial is for healthy volunteers who want to help test a new drug called VK4-116. It's not for people with opioid use disorder or addiction, but the results might one day help those who do.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single ascending dose of VK4-116 or placebo and are monitored for safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VK4-116
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Drug Abuse (NIDA)
Lead Sponsor
Altasciences Company Inc.
Industry Sponsor