VK4-116 for Opioid Use Disorder

Overseen ByDebra Kelsh, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: Opioids, Benzodiazepines, others

Disqualifiers: Cardiac, Hepatic, Renal, Neurologic, others

Trial Summary

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?

There is no specific safety data available for VK4-116 in humans, but studies in animals suggest it may be safe as it did not compromise pain relief effects while reducing opioid self-administration.¹ ² ³ ⁴ ⁵

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.² ⁵ ⁶ ⁷ ⁸

Research Team

Marta De Santis, PhD

Principal Investigator

National Institute on Drug Abuse, NIH

Eligibility Criteria

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

I am following the required birth control guidelines.

Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures

Be able and willing to comply with protocol requirements and the rules and regulations of the study site, and be likely to complete all the study treatments

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Exclusion Criteria

Use nicotine products via smoking/vaping in past 6 months

I have a history of heart conditions.

Have any clinically significant finding within one year of Screening that contraindicates participation in the study

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a single ascending dose of VK4-116 or placebo and are monitored for safety, tolerability, and pharmacokinetics

4 days for fasted condition, 8 days for fed condition

Continuous monitoring during clinic stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

1 visit (in-person)

Treatment Details

Interventions

VK4-116

Trial Overview VK4-116 is being tested in this study. Volunteers will take different doses of the drug or a placebo without knowing which they're getting. The study looks at how safe it is and how the body processes it when taken with and without food.

Participant Groups

7Treatment groups

Experimental Treatment

Placebo Group

Group I: 500 mg doseExperimental Treatment1 Intervention