Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

NCT07531316 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: HM200327171UG3DA063353
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Controls

Outcome Measures

Primary Outcomes (1)

• Safety

  Adverse event data will be compiled for VVZ-2471 and placebo cohorts and presented as summary statistics.

  from baseline to end of 14 day treatment

Secondary Outcomes (2)

• Impulsivity

  Time Frame: from baseline to end of 14 day treatment

• Tolerability of VVZ-2471

  from baseline to end of 14 day treatment

Other Outcomes (1)

• Maximum Plasma Concentration (Cmax) at Day 7 in Sentinel group (Interim PK analysis)

  Study day 1-7

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo pills for 14-day intervention

VVZ-2471

EXPERIMENTAL

Study Medication

Drug: VVZ-2471 for 14-day intervention

Sentinel group (first 10 participants)

OTHER

The sentinel group group of 10 participants (2 placebo treated and 8 VVZ-2471 treated) will undergo PK testing at study day 7 which will be reviewed by the DSMB to ensure the PK parameters do not reach stopping criteria based on unbound exposure levels (Cmax: 39.75 ng/mL and AUC0-24: 410.82 ng h/mL). If the exposure levels do not reach stopping criteria, dosing may proceed in remaining participants.

Drug: Placebo pills for 14-day intervention; Drug: VVZ-2471 for 14-day intervention

Interventions

Placebo pills for 14-day intervention DRUG

Subjects 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.

Placebo; Sentinel group (first 10 participants)

VVZ-2471 for 14-day intervention DRUG

100 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.

Sentinel group (first 10 participants); VVZ-2471

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• 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.
• Cardiac Safety: QTcF interval \< 450 ms and ECG findings considered normal or not clinically significant at screening by the PI/designee.
• Laboratory Values: Clinical labs completed during screening must meet the following safety thresholds:
• Serum creatinine, AST, ALT, BUN: \< 1.5 x Upper Limit of Normal (ULN)
• Platelet count: \>140 x 10⁹/L
• INR: \< 1.2
• PT/aPTT: \< 1.2 x ULN

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Psychiatric \& Substance Use
• 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.
• Medical \& Neurological
• 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.
• Bleeding \& Coagulation: Recent history (within 6 months) of clinically significant bleeding; or history of intracranial hemorrhage, subdural/epidural hematoma, hemorrhagic stroke, AVM, or bleeding diatheses.
• Systemic Disease: History of malignancy (cancer), or significant respiratory, gastrointestinal, renal, urological, reproductive, endocrine, dermatological, or metabolic disorders.11. Liver/Pancreas: Pancreatic or liver disease that currently requires medical treatment.
• \. Positive HIV, HCV or HBC test results indicative of HIV infection or active hepatitis B or hepatitis C infection.
• Medications \& Interactions 13. CYP3A4 Interactions: Currently taking prescription/OTC drugs or supplements known to significantly inhibit CYP3A4 (e.g., clarithromycin, ketoconazole, ritonavir, grapefruit juice) or induce CYP3A4 (e.g., phenobarbital, rifampicin, St. John's Wort).

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Virginia Commonwealth University: lead

Study Sites (1)

VCU Institute for Drug and Alcohol Studies

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• F. Gerard Moeller, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Pignatello, FNP

CONTACT

804-828-3686; study4u@vcu.edu

Lori Keyser-Marcus, PhD

CONTACT

Lakeyser@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double-blind randomized clinical trial

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: April 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 20, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)