CVL-354 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CVL-354 in healthy participants to observe how different doses affect the body. The trial consists of two parts: one tests single doses, and the other tests multiple doses over time. Participants will receive either the treatment or a placebo, a look-alike substance with no active ingredients, to compare results. The trial seeks healthy volunteers aged 18 to 55 with no serious health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial requires participants to avoid certain medications, including prescription and over-the-counter drugs, herbal medications, vitamins, and supplements. You may need to stop taking your current medications if they are considered prohibited for the trial.
Is there any evidence suggesting that CVL-354 is likely to be safe for humans?
Research has shown that CVL-354 blocks certain brain receptors linked to mood and behavior. In animal studies, this drug reduced signs of opioid withdrawal, suggesting a calming effect without major harm.
The current trial is in its early phase, focusing on testing the drug's safety in humans. This phase typically involves small groups to observe how the body reacts to the drug. While specific data on human response to CVL-354 is not yet available, its testing in humans indicates it passed initial safety checks in earlier animal studies.
If the FDA had already approved CVL-354 for another condition, it might provide more confidence in its safety. However, that is not the case here, so the main safety evidence comes from animal studies and this early trial phase. Consulting a healthcare professional before joining any trial is always advisable.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CVL-354 because it offers a novel approach to treating conditions that involve the brain's receptors. Unlike the standard options that generally target common neurotransmitter pathways, CVL-354 specifically locks onto the kappa opioid receptors, which might lead to fewer side effects and better effectiveness in managing mood and anxiety disorders. This targeted action is particularly promising for those who haven’t found relief with existing treatments, and it may provide a faster onset of benefits.
What evidence suggests that this trial's treatments could be effective?
Research shows that CVL-354 is a promising new treatment under study for its effects on certain brain receptors that help control mood and stress. In this trial, participants will receive different dosages of CVL-354 or a placebo to evaluate its effects. Animal studies have shown that CVL-354 can reduce physical signs of withdrawal from opioids, suggesting it could help manage symptoms related to opioid use. Although limited data from human studies exist, early results support its expected effects in the brain, offering hope for its effectiveness in treating related conditions.12467
Who Is on the Research Team?
Matthew Leoni, MD, MBA
Principal Investigator
Cerevel Therapeutics, LLC
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive single ascending doses of CVL-354 in a 4-way crossover design with washout periods
Treatment Part B
Participants receive multiple ascending doses of CVL-354 or placebo once daily for 14 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CVL-354
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLC
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator