VK4-116 for Opioid Use Disorder

Overseen ByDebra Kelsh, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Institute on Drug Abuse (NIDA)

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.

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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Treatment Details

Interventions

VK4-116 (Anti-tumor antibiotic)

Trial OverviewVK4-116 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