VK4-116 Phase I Study With Food-Effect

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
National Institute on Drug Abuse (NIDA)
Study ID
NCT06808932
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Opioid Dependence
  • Opioid Use Disorder (OUD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • VK4-116 — DRUG
    D3R antagonist
  • Placebo — DRUG
    Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Aug 30, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 50 mg dose
    oral administration in fasted state
  • Experimental: 100 mg dose
    oral administration in fasted state
  • Experimental: 200 mg dose
    oral administration in fasted state
  • Experimental: 400 mg dose
    oral administration in fasted state
  • Experimental: 500 mg dose
    oral administration in fasted state
  • Experimental: 200 mg dose in fed state
    oral administration in fed state
  • Placebo Comparator: placebo
    oral administration

Primary Outcome Measure

Number of Treatment-Emergent Adverse Events in Healthy Adult Participants [ Time Frame: 7 days for fasted condition, 11 days for fed condition ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences Clinical KansasOverland ParkKansas66212
Debra Kelsh, MD
[email protected]
913-696-1601

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By research site
Altasciences Clinical Kansas· Overland Park, KS

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