MedTrace Logo

Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

NCT07531316 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-09-01

No results posted yet for this study

Summary

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/).

Conditions

  • Healthy Controls

Interventions

DRUG

Placebo pills for 14-day intervention

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.

DRUG

VVZ-2471 for 14-day intervention

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • F. Gerard Moeller, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-28
Primary Completion
2031-12-20
Completion
2031-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531316 on ClinicalTrials.gov