Safety and Tolerability Study of VVZ-2471 in Healthy Volunteers

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT07531316
Phase
PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Healthy Controls

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Dec 20, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Placebo Comparator: Placebo
    Placebo
  • Experimental: VVZ-2471
    Study Medication
  • Other: Sentinel group (first 10 participants)
    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.

Primary Outcome Measure

Safety [ Time Frame: from baseline to end of 14 day treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VCU Institute for Drug and Alcohol StudiesRichmondVirginia23219-

Find similar trials in Richmond, VA

By research site
VCU Institute for Drug and Alcohol Studies· Richmond, VA

Related Studies