Health TrialsbyHealthPanel

VK4-116 Phase I Study With Food-Effect

ConditionsOpioid DependenceOpioid Use Disorder (OUD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNational Institute on Drug Abuse (NIDA)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: 50 mg doseExperimental treatment 1 intervention
Group B: 100 mg doseExperimental treatment 1 intervention
Group C: 200 mg doseExperimental treatment 1 intervention
Group D: 400 mg doseExperimental treatment 1 intervention
Group E: 500 mg doseExperimental treatment 1 intervention
Group F: 200 mg dose in fed stateExperimental treatment 1 intervention
Group G: placeboPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
7 days for fasted condition, 11 days for fed condition

Secondary outcomes

1

Cmax

maximum observed plasma concentration (ng/mL)

Time frame
72 hours
2

AUC

area under the concentration-time curve (mg\*h/L)

Time frame
72 hours
3

Tmax

time of maximum observed plasma concentration (hours)

Time frame
72 hours
4

half life (t½)

VK4-116 elimination half-life (hours)

Time frame
72 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute on Drug Abuse (NIDA)

Lead sponsor

Altasciences Company Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: