Opioid DependencePhase 1NCT06808932
VK4-116 Phase I Study With Food-Effect
A Phase 1 study testing VK4-116 in people with Opioid Dependence and Opioid Use Disorder (OUD), run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Opioid Use Disorder (OUD)
- What is being tested?
- VK4-116
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 30 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- 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:
- 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.
Who cannot join
- 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).
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- 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.
- 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).
- Have a positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCVAb), or human immunodeficiency virus (HIV).
- Have positive results for a coronavirus disease 2019 (COVID-19) test.
- Have a history of anaphylaxis and known allergy to any drug formulation.
- 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.
- Have consumed any product containing caffeine or xanthine within 24 hours before study drug dosing on Day 1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Altasciences Clinical Kansas
Overland Park, Kansas, 66212
Debra Kelsh, MD, 913-696-1601, DKelsh@altasciences.com
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study With Food-Effect Cohort to Assess the Safety, Tolerability, and Pharmacokinetics of Oral (R) VK4-116 in Healthy Volunteers
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.
Read the detailed description
Approximately 48 healthy volunteers will be enrolled and randomized to receive either VK4-116 or a placebo within one of five ascending dose cohorts. Each cohort will consist of eight participants, with a 6:2 ratio of active drug to placebo assignment. Dose escalation decisions will be made following a review of blinded safety, tolerability, and pharmacokinetic (PK) data from the preceding cohort.
The proposed dose levels under fasting conditions are 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg. Additional cohort will receive a 200 mg dose in a fed state, approximately 30 minutes after a high-fat, high-calorie breakfast. Dose adjustments may be made based on the safety, tolerability, and PK data observed in earlier cohorts.
Participants will be admitted to the research clinic one day prior to receiving their assigned treatment. Following the administration of VK4-116 or placebo, participants will be continuously monitored for adverse events, and PK blood samples will be collected at predetermined intervals. Participants will remain in the clinic for 4 days, until the 72-hour PK blood sample has been collected. Participants in the food-effect cohort will stay in the clinic for 8 days (for fasted stat followed by fed state assessments). A follow-up visit will be scheduled three days after discharge from the clinic.
- Conditions
- Opioid Dependence, Opioid Use Disorder (OUD)
- Being tested
- VK4-116, Placebo
- Keywords
- addiction, dopamine, dopamine receptor
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VK4-116Drug
D3R antagonist
PlaceboDrug
Each of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2.
| Study group | Role | What they receive |
|---|---|---|
| 50 mg dose | Experimental | oral administration in fasted state Receives: Drug: VK4-116 |
| 100 mg dose | Experimental | oral administration in fasted state Receives: Drug: VK4-116 |
| 200 mg dose | Experimental | oral administration in fasted state Receives: Drug: VK4-116 |
| 400 mg dose | Experimental | oral administration in fasted state Receives: Drug: VK4-116 |
| 500 mg dose | Experimental | oral administration in fasted state Receives: Drug: VK4-116 |
| 200 mg dose in fed state | Experimental | oral administration in fed state Receives: Drug: VK4-116 |
| placebo | Placebo comparator | oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days for fasted condition, 11 days for fed condition
Secondary outcomes (4)
Cmax
maximum observed plasma concentration (ng/mL)
Measured: 72 hours
AUC
area under the concentration-time curve (mg*h/L)
Measured: 72 hours
Tmax
time of maximum observed plasma concentration (hours)
Measured: 72 hours
half life (t½)
VK4-116 elimination half-life (hours)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Marta De Santis, PhD, Study director, National Institute on Drug Abuse, NIH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808932
- Sponsor's protocol ID
- NIDA-VK4-116-Ph1a-001
- Status last verified
- Apr 2026
- First submitted
- 22 Jan 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study With Food-Effect Cohort to Assess the Safety, Tolerability, and Pharmacokinetics of Oral (R) VK4-116 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06808932
- Acronym / sponsor ID
- NIDA-VK4-116-Ph1a-001
- Conditions
- Opioid Dependence, Opioid Use Disorder (OUD)
- Keywords
- addiction, dopamine, dopamine receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Altasciences Company Inc.
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 48 healthy volunteers will be enrolled and randomized to receive either VK4-116 or a placebo within one of five ascending dose cohorts. Each cohort will consist of eight participants, with a 6:2 ratio of active drug to placebo assignment. Dose escalation decisions will be made following a review of blinded safety, tolerability, and pharmacokinetic (PK) data from the preceding cohort.
The proposed dose levels under fasting conditions are 50 mg, 100 mg, 200 mg, 400 mg, and 500 mg. Additional cohort will receive a 200 mg dose in a fed state, approximately 30 minutes after a high-fat, high-calorie breakfast. Dose adjustments may be made based on the safety, tolerability, and PK data observed in earlier cohorts.
Participants will be admitted to the research clinic one day prior to receiving their assigned treatment. Following the administration of VK4-116 or placebo, participants will be continuously monitored for adverse events, and PK blood samples will be collected at predetermined intervals. Participants will remain in the clinic for 4 days, until the 72-hour PK blood sample has been collected. Participants in the food-effect cohort will stay in the clinic for 8 days (for fasted stat followed by fed state assessments). A follow-up visit will be scheduled three days after discharge from the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 50 mg dose | Experimental | Drug: VK4-116oral administration in fasted state |
| 100 mg dose | Experimental | Drug: VK4-116oral administration in fasted state |
| 200 mg dose | Experimental | Drug: VK4-116oral administration in fasted state |
| 400 mg dose | Experimental | Drug: VK4-116oral administration in fasted state |
| 500 mg dose | Experimental | Drug: VK4-116oral administration in fasted state |
| 200 mg dose in fed state | Experimental | Drug: VK4-116oral administration in fed state |
| placebo | Placebo comparator | Drug: Placebooral administration |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be a healthy male or female volunteer between 18 and 60 years of age, inclusive, at the time of consent.
- 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:
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VK4-116D3R antagonist | Drug | 100 mg dose, 200 mg dose, 200 mg dose in fed state, 400 mg dose, 50 mg dose, 500 mg dose |
| PlaceboEach of the four dose groups of n=8 participants will be assigned to active drug or placebo in the ration 6:2. | Drug | placebo |
Primary outcome
Number of Treatment-Emergent Adverse Events in Healthy Adult Participants
Time frame: 7 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
4 secondary outcomes
Cmax
Time frame: 72 hours
AUC
Time frame: 72 hours
Tmax
Time frame: 72 hours
half life (t½)
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta De Santis, PhD study director
National Institute on Drug Abuse, NIH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VK4-116 in people with Opioid Dependence and Opioid Use Disorder (OUD), run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debra Kelsh, MD (913-696-1601, DKelsh@altasciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.