Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers (NCT07531316) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers
United States60 participantsStarted 2026-06-01
Plain-language summary
The goal of this study is to do follow-up safety testing and how well people are able tolerate 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Vital Signs (Resting): Resting pulse between 55 and 95 bpm; Systolic Blood Pressure between 90-120 mmHg; Diastolic Blood Pressure between 50-80 mmHg.
✓. Vital Signs (Orthostatic): A set of orthostatic vital signs completed during screening and on each study visit demonstrating a decrease in Systolic Blood Pressure\< 20 mmHg and Diastolic Blood Pressure \<10 mmHg upon standing.
✓. BMI: Body Mass Index between 18.5 and 35 kg/m².
✓. Toxicology: Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening.
Exclusion criteria
✕. 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.
What they're measuring
1
Safety
Timeframe: from baseline to end of 14 day treatment
✕. 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.
✕. Neurological Disorders: History of neurological disorders including epilepsy or a family history of epilepsy, intractable/complicated migraine syndromes, cluster headache syndrome, extrapyramidal/pyramidal disorders, cerebrovascular, or degenerative disorders.
✕. Seizure History: Any lifetime history of seizure.
✕. Traumatic Brain Injury (TBI): Lifetime history of brain injury with loss of consciousness \> 30 minutes, Past-year brain injury with loss of consciousness \< 30 minutes.
✕. Cardiovascular Conditions: History of heart failure, cardiomyopathy, sick sinus syndrome, second or third-degree AV block, myocardial infarction, pulmonary congestion, symptomatic/significant cardiac arrhythmia, or clinically significant abnormal conduction on baseline ECG.