60 Participants NeededMy employer runs this trial

VVZ-2471 for Healthy Volunteers

TP
LK
Overseen ByLori Keyser-Marcus, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Virginia Commonwealth University

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerance of an experimental medication called VVZ-2471 in healthy volunteers. It aims to gather information to aid in developing future studies for individuals who use substances. Participants will receive either the medication or a placebo (an inactive substance). Ideal candidates are adults in good health who do not use illicit drugs. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new medication.

Do I have to stop taking my current medications?

You may need to stop taking certain medications before joining this trial. Specifically, if you are taking drugs that affect CYP3A4 or certain central nervous system medications, you might need to discontinue them. It's best to discuss your current medications with the study team to see if any changes are needed.

Is there any evidence suggesting that VVZ-2471 is likely to be safe for humans?

Research has shown that VVZ-2471 was tested in healthy individuals and found to be safe. In these studies, participants received both single and multiple doses. The most common side effects were mild, such as headaches and dizziness, and resolved on their own.

The treatment targets specific parts of the brain and was well-tolerated in previous tests, meaning most people handled it without major issues. Overall, past research indicates that VVZ-2471 has a good safety record, suggesting it is likely safe for participants in this trial.12345

Why do researchers think this study treatment might be promising?

VVZ-2471 is unique because it represents a new approach in its field, potentially offering a novel mechanism of action that distinguishes it from existing treatments. While standard treatments often rely on established mechanisms, VVZ-2471 might introduce a fresh active ingredient or innovative delivery method that could enhance its effectiveness or safety profile. Researchers are particularly excited about VVZ-2471 because it could target the condition more precisely, potentially leading to improved outcomes and offering a new option for patients who may not respond well to current therapies.

What evidence suggests that VVZ-2471 could be effective?

Research suggests that VVZ-2471 might help with issues related to drug use. In earlier studies with rats, VVZ-2471 showed potential in treating drug addiction and anxiety. This drug affects two specific brain receptors, 5-HT2A and mGluR5, which are linked to these issues. Early human tests have shown that VVZ-2471 is generally safe, with nausea and dizziness as the most common side effects. Additionally, studies with smokers revealed that those who took VVZ-2471 experienced fewer urges to smoke. These findings suggest VVZ-2471 could help manage behaviors related to drug use. In this trial, participants will receive either VVZ-2471 or a placebo to further evaluate its safety and effects.12345

Who Is on the Research Team?

FG

F. Gerard Moeller, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who show high impulsivity on a specific test, are in good general health, do not use illicit drugs or alcohol, and meet certain medical criteria. Women must not be able to become pregnant; men must use effective birth control.

Inclusion Criteria

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
Urine drug test negative for non-prescribed substances and a breath (or oral fluid) alcohol screen negative during screening
Must be able to understand study procedures, follow instructions, and provide written informed consent in the English language
See 9 more

Exclusion Criteria

I have had serious bleeding, stroke, or brain bleeding recently.
Lifetime history of brain injury with loss of consciousness > 30 minutes, past-year brain injury with loss of consciousness < 30 minutes
Any lifetime history of psychosis or bipolar disorder
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to take the study medication or placebo twice daily for 14 days. The study includes physical exams, bloodwork, ECGs, vital signs, psychological surveys, and computer tasks.

2 weeks
Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • VVZ-2471

Trial Overview

The study tests the safety and tolerability of an experimental drug called VVZ-2471 compared to placebo pills over 14 days. Participants are randomly assigned to receive either the new medication or placebo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: VVZ-2471Experimental Treatment1 Intervention
Group II: Sentinel group (first 10 participants)Experimental Treatment2 Interventions
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

VVZ-2471 for Healthy Volunteers · Info for Participants

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 .

Safety and Tolerability Study of VVZ-2471 in Healthy ...

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 .

Novel 5-HT2A/mGluR5 Antagonist for Opioid Use Disorder

In human studies, single and multiple ascending dose studies showed VVZ-2471 to be safe in healthy controls with the most common adverse events being ...

Safety and Tolerability Study of VVZ-2471 in Healthy ...

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 ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40234362/

Evaluation of Safety, Pharmacokinetic, and ...

This study aimed to evaluate the safety and pharmacokinetic (PK)-pharmacodynamic (PD) characteristics of VVZ-2471 capsules in healthy Korean adults. Methods ...