Safety Study of VVZ-2471 in Healthy Volunteers

This study is testing the safety and how well people tolerate an experimental medication called VVZ-2471. We are looking for healthy adults, aged 18 to 65, who show high impulsivity during screening. You would be randomly assigned to take either VVZ-2471 or a placebo (an inactive pill) twice daily for 14 days. This study aims to understand the effects of VVZ-2471 in healthy individuals, which will help us plan future studies for people who use substances. The main goal is to check for any side effects or problems with the medication.

Study design
This is an interventional study with a planned enrollment of 60 healthy volunteers. Participants will be randomly assigned to receive either VVZ-2471 or a placebo.
What's involved
You would take a pill twice daily for 14 days. This involves multiple study visits for physical exams, bloodwork, heart tests (ECGs), vital signs, surveys, computer tasks, and urine drug screens.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from the start of the study until the end of the 14-day treatment period.

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NCT07531316

Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

Recruiting
PHASE1Ages 18–65Interventional
Virginia Commonwealth University
~60 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Placebo pills for 14-day interventionVVZ-2471 for 14-day intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety-AE Data
Measured over from baseline to end of 14 day treatment
Healthy Controls
1 sites across 1 states
Virginia1
  • F. Gerard Moeller, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

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Eligibility criteria

Inclusion

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
Fibrinogen: \> 175 mg/dL 11. Female Participants: Must not be of childbearing potential. They must be either post-menopausal or surgically sterile. They must not be pregnant or breastfeeding. 12. Male Participants: Male subjects of reproductive potential must use a highly effective contraceptive method from first dose through 90 days after the last dose and to refrain from sperm donation during the same period.
  • Safety-AE Datafrom baseline to end of 14 day treatment

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