NCT06808932

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

January 22, 2025

Last Update Submit

April 6, 2026

Conditions

Opioid DependenceOpioid Use Disorder (OUD)

Keywords

addictiondopaminedopamine receptor

Outcome Measures

Primary Outcomes (1)

  • Number of Treatment-Emergent Adverse Events in Healthy Adult Participants

    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

    7 days for fasted condition, 11 days for fed condition

Secondary Outcomes (4)

  • Cmax

    72 hours

  • AUC

    72 hours

  • Tmax

    72 hours

  • half life (t½)

    72 hours

Study Arms (7)

50 mg dose

EXPERIMENTAL

oral administration in fasted state

Drug: VK4-116

100 mg dose

EXPERIMENTAL

oral administration in fasted state

Drug: VK4-116

200 mg dose

EXPERIMENTAL

oral administration in fasted state

Drug: VK4-116

400 mg dose

EXPERIMENTAL

oral administration in fasted state

Drug: VK4-116

500 mg dose

EXPERIMENTAL

oral administration in fasted state

Drug: VK4-116

200 mg dose in fed state

EXPERIMENTAL

oral administration in fed state

Drug: VK4-116

placebo

PLACEBO COMPARATOR

oral administration

Drug: Placebo

Interventions

VK4-116DRUG

D3R antagonist

100 mg dose200 mg dose200 mg dose in fed state400 mg dose50 mg dose500 mg dose
PlaceboDRUG

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

placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent.
  • The masculine / feminine gender is used without any discrimination and with the aim to lighten the text.
  • Have a body mass index (BMI) within a range of 17.0 to 36.0 kg/m2 and a minimum weight of at least 50.0 kg at screening.
  • Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures.
  • Have no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
  • A female study participant must meet one of the following criteria:
  • 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:
  • i. abstinence from heterosexual intercourse, ii. hormonal contraceptives (e.g., injectable/implant/insertable hormonal birth control products, transdermal patch), iii. intrauterine device (with or without hormones). OR agrees to use a double barrier method (e.g., condom and spermicide) during the study and for at least 30 days after the last dose of the study medication.
  • 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).
  • A male study participant that engages in sexual activity must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication.
  • 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.

You may not qualify if:

  • Have any clinically significant finding within one year of Screening on medical history, physical examination, complete neurological examination, clinical laboratory test, vital signs or ECGs that contraindicate participation in the study. This includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal (GI), pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy.
  • Use nicotine products via smoking/vaping in past 6 months.
  • Have a sitting systolic blood pressure (BP) \>140 mmHg, diastolic BP \>90 mmHg and heart rate (HR) \<45 or \>100 beats per minute (BPM) at screening and clinic intake.
  • History of unstable angina; a history of myocardial infarction; or a history of a clinically significant cardiac arrhythmia,
  • Has a QT interval corrected for heart rate using Fredericia formula \>450 milliseconds in males or \>470 milliseconds in females, or evidence of left bundle branch blocks (Note: right bundle branch block is acceptable), second or third degree AV block, or evidence of left ventricular hypertrophy on ECG
  • Have a history of liver disease or current elevation of aspartate aminotransferase (AST), alanine aminotransferase (ALT), 2 × the upper limit of normal (ULN).
  • Have a history of renal disease or current renal function test values as follows:
  • blood urea nitrogen (BUN) \>2 × ULN,
  • creatinine (Cr) \>1.5 mg/dL.
  • Have donated blood (excluding plasma donation) of approximately 500 mL within 56 days prior to screening.
  • Have donated plasma within 7 days prior to screening.
  • Have hemoglobin value of \<13 g/dL for men and \<12 g/dL for women.
  • Have undergone treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening.
  • 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.
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altasciences Clinical Kansas

Overland Park, Kansas, 66212, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, Addictive

Interventions

VK4-116

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Marta De Santis, PhD

    National Institute on Drug Abuse, NIH

    STUDY DIRECTOR

Central Study Contacts

Debra Kelsh, MD

CONTACT

913-696-1601DKelsh@altasciences.com

Sage Hannan, BA

CONTACT

913-696-1601shannan@altasciences.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: This is first-in-human (FIH), randomized, double-blind, placebo-controlled, single ascending dose (SAD), phase I study in healthy participants. Five single ascending dose levels under fasting conditions are proposed. This study will also provide a preliminary assessment of the potential effect of food on the dose corresponding to approximately 40% of the maximum safe and well-tolerated dose.
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

February 5, 2025

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

August 30, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

US(1)