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VK4-116 Study for Opioid Dependence

This study is testing a new drug called VK4-116, which is a D3R antagonist, to see how safe it is, how well your body tolerates it, and how it moves through your system. It's for healthy volunteers aged 18 to 60 years old. The study will look at any side effects (adverse events) you might experience over 7 to 11 days. We don't know the current recruitment status, but it plans to enroll about 48 participants. This is a first-in-human study, meaning it's the first time this drug is being tested in people.

Study design
This is a randomized, double-blind, placebo-controlled study with single ascending doses, meaning you'll either receive VK4-116 or a placebo (an inactive substance), and neither you nor the study staff will know which you're getting. It will involve about 48 healthy volunteers.
What's involved
You will be admitted to a research clinic one day before treatment and stay for 4 days (or 8 days if you're in the food-effect group). During this time, you'll be monitored for side effects and have blood samples taken. A follow-up visit will be scheduled three days after you leave the clinic.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 7 days if you're in the fasted condition group, or 11 days if you're in the fed condition group, to monitor for adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06808932

VK4-116 Phase I Study With Food-Effect

Not Yet Recruiting
PHASE1Ages 18–60InterventionalTreatment
National Institute on Drug Abuse (NIDA)
~48 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:VK4-116Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Treatment-Emergent Adverse Events in Healthy Adult Participants
Measured over 7 days for fasted condition, 11 days for fed condition

Conditions

Opioid Dependence
Opioid Use Disorder (OUD)

Explore related trials

Opioid DependenceOpioid Use Disorder

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Marta De Santis, PhD · STUDY_DIRECTOR · National Institute on Drug Abuse, NIH

Who to contact

Debra Kelsh, MD
[email protected]
913-696-1601
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

If of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the first administration of the study medication, during the study, and for at least 30 days after the last dose of the study medication. An acceptable method of contraception includes one of the following:
If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle stimulating hormone (FSH) levels (≥40 mIU/mL).

Exclusion

blood urea nitrogen (BUN) \>2 × ULN,
creatinine (Cr) \>1.5 mg/dL. 8. Have donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening. 9. Have donated plasma within 7 days prior to screening. 10. Have hemoglobin value of \<13 g/dL for men and \<12 g/dL for women. 11. Have undergone treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening. 12. Have taken prescribed medications within 14 days of Day -1 or over-the-counter medications, dietary supplements, herbal products, or vitamins within 7 days or 5 half-lives (if known), whichever is longer, of Day -1. 13. Have a positive urine drug test for alcohol, opioids (e.g., codeine, heroin, fentanyl, morphine, oxycodone, etc.), cocaine, amphetamine, methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), benzodiazepines, tetrahydrocannabinol (THC), barbiturates, propoxyphene, or phencyclidine/phenylcyclohexyl piperidine (PCP) at admission. 14. Have a history of suicide attempts or current or recent evidence of suicidal ideation in the past 12 months based on the Columbia-Suicide Severity Rating Scale (C-SSRS). 15. Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV). 16. Have positive results for a coronavirus disease 2019 (COVID-19) test. 17. Have a history of anaphylaxis and known allergy to any drug formulation. 18. Have a history of consumption of any product containing grapefruit, pomelo, Seville oranges, or alcohol within 7 days before study drug dosing on Day 1. 19. Have consumed any product containing caffeine or xanthine within 24 hours before study drug dosing on Day 1

What this trial measures

  • Number of Treatment-Emergent Adverse Events in Healthy Adult Participants7 days for fasted condition, 11 days for fed condition

    The number of treatment-emergent adverse events will be measured using a combination of data collection methods, including tracking adverse events and assessing their onset or worsening relative to the initiation of treatment. The most recent version of the Medical Dictionary for Regulatory Activities (MedDRA) preferred terms will be used to classify adverse events, including their relationship to the treatment and maximum severity. Events will be identified either through subject self-report or clinically significant abnormal findings on: (i) Physical examination (ii) Vital signs assessments (heart rate (BPM), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), respiration rate (RPM), and temperature (F)) (iii) ECG assessment (QTcF) as determined by the Investigator/consulting board-certified cardiologist (iv) Clinical Laboratory Assessments