Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
ConditionHealthy Controls
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVirginia Commonwealth University
About this trial
The goal of this study is to do follow-up testing on the safety and tolerability of an experimental (not FDA approved) medication. This study is seeking non-illicit drug using adults to test the medication. Results of this study will help us to develop future studies to test the medication with people who use substances. This research is supported by and included in the NIH HEAL Initiative (https://heal.nih.gov/).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Demographics: Male or female, between 18 and 65 years of age.
High Impulsivity: Must demonstrate high impulsivity during the screening period, defined as an Immediate Memory Task (IMT) Commission Error by Correct Deletions (CE/CD) ratio > 0.25.
Informed Consent: Able to understand study procedures, follow instructions, and provide written informed consent in the English language.
Health Status: Be in generally good health based on medical history, physical exam, clinical laboratory values, vital signs, and ECG done during the screening period, as deemed by the Principal Investigator (PI) or designee.
Disqualifiers
Psychosis and bipolar disorder: Any lifetime history of psychosis or bipolar disorder.
Current Psychiatric Disorder: Current or recent (within the last year) DSM-5 diagnosis of any other psychiatric disorder that would make study participation unsafe, including but not limited to depressive disorders, trauma- or stress related disorders, and anxiety disorders that in the opinion of the investigator would make study participation unsafe.
Substance Use Disorder: Current DSM-5 diagnosis (any severity) of an alcohol or drug use disorder, or use of illicit/non-prescribed substances within the last 12 months.
Suicidality: Current or recent suicidal or homicidal ideation (C-SSRS "yes" answers on any questions) or a history of suicide attempt within the past 12 months.
Trial design
Design model
Parallel
Treatments tested in this trial
Placebo pills for 14-day intervention
DrugSubjects who are randomized to placebo will receive identical capsules to the study drug. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.
VVZ-2471 for 14-day intervention
Drug100 mg/BID. Subjects who are randomized to VVZ-2471 will receive identical capsules to the placebo. During the 14-day intervention phase, participants will be instructed to take one capsule twice daily.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: VVZ-2471Experimental treatment 1 intervention
Group C: Sentinel group (first 10 participants)Other 2 interventions
Trial outcomes
Primary outcomes
1
Safety-AE Data
Adverse event data will be compiled for VVZ-2471 and placebo cohorts and presented as summary statistics.
Time frame
from baseline to end of 14 day treatmentSecondary outcomes
1
Impulsivity-Commision Errors
Impulsivity as measured by commission errors divided by correct detections on the immediate memory task.
Time frame
Time Frame: from baseline to end of 14 day treatment2
Tolerability of VVZ-2471
Subjective participant-related medication effects as measured by a visual analog scale (VAS).
Time frame
from baseline to end of 14 day treatmentOther outcomes
1
Maximum Plasma Concentration (Cmax) at Day 7 in Sentinel group (Interim PK analysis)
PK testing at day 7 for the first 10 participants (Sentinel group). If PK parameters do not reach stopping criteria based on unbound exposure levels levels (Cmax: 39.75 ng/ml and AUC 0-24; 410.82 ng h/mL), dosing may proceed in remaining participants
Time frame
Study day 1-7Sponsors and contacts
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Virginia Commonwealth University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov