MedTrace Logo

VK4-116 Phase I Study With Food-Effect

NCT06808932 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-04-09

No results posted yet for this study

Summary

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.

Conditions

  • Opioid Dependence
  • Opioid Use Disorder (OUD)

Interventions

DRUG

VK4-116

D3R antagonist

DRUG

Placebo

Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.

Sponsors & Collaborators

  • Altasciences Company Inc.

    collaborator INDUSTRY

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-04-30
Completion
2027-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06808932 on ClinicalTrials.gov