VK4-116 for Opioid Use Disorder

Recruiting in Palo Alto (17 mi)

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.

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 don't have any serious health issues besides my current condition.

My BMI is between 17.0 and 36.0, and I weigh at least 50 kg.

I am between 18 and 60 years old and consider myself healthy.

I am a man who agrees to use double contraception and not donate sperm.

Exclusion Criteria

I have a history of heart conditions.

I have followed dietary restrictions before taking the study drug.

I have a history of liver disease or high liver enzymes.

I have a history of kidney disease or abnormal kidney tests.

Participant Groups

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.

7Treatment groups

Experimental Treatment

Placebo Group

Group I: 500 mg doseExperimental Treatment1 Intervention

oral administration in fasted state

Group II: 50 mg doseExperimental Treatment1 Intervention

oral administration in fasted state

Group III: 400 mg doseExperimental Treatment1 Intervention

oral administration in fasted state

Group IV: 200 mg dose in fed stateExperimental Treatment1 Intervention

oral administration in fed state

Group V: 200 mg doseExperimental Treatment1 Intervention