VVZ-2471 for Healthy Volunteers
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Study Medication
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.
Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Virginia Commonwealth University
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
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 ...
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 ...
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