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Opioid Receptor Agonist

CVL-354 for Opioid Receptor Occupancy

Phase 1
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (1.25, 2.0, and 2.75 hours post dose)
Awards & highlights

Study Summary

This trial tests a drug to see how it affects opioid receptors in the brain in healthy adults.

Who is the study for?
This trial is for healthy adults aged 18-55 with a BMI of 18.5 to 32 kg/m^2 and weight over 50 kg. Participants must not have any significant medical conditions, recent COVID-19 infection or vaccination, drug/alcohol abuse history within the last year, or be on prohibited medications. Men must agree to use contraception during the trial.Check my eligibility
What is being tested?
The study tests how well CVL-354 occupies kappa and mu opioid receptors in the brain after oral dosing in healthy participants. It involves PET scans using [11C]-LY2795050 and [11C]-carfentanil to measure this target occupancy.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions from PET imaging agents like discomfort at injection site or allergic reactions, as well as any unforeseen effects of CVL-354 on brain function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (1.25, 2.0, and 2.75 hours post dose)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (1.25, 2.0, and 2.75 hours post dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain
Mu Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Secondary outcome measures
Area Under the Plasma Concentration-time Curve (AUC) of CVL-354 for Scan Duration
Average Plasma Concentration (Cavg) of CVL-354 for Scan Duration
Maximum Observed Plasma Concentration (Cmax) of CVL-354 During Scan
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Mu Opioid Receptor (MOR) CohortExperimental Treatment2 Interventions
Part B will commence after Part A cohort is completed. Participants will receive single dose of CVL-354 150 mg, orally, on Day 1 along with [11C]-carfentanil, IV bolus injection of up to 20 mCi before the baseline and post-dose PET scans. Based on the MOR RO results from this cohort, dosing may be explored further in subsequent cohorts.
Group II: Part A: Kappa Opioid Receptor (KOR) CohortExperimental Treatment2 Interventions
Participants will receive single dose of CVL-354, 25 mg, orally, on Day 1 along with [11C]-LY2795050, intravenous (IV) bolus injection of up to 20 millicurie (mCi) before the baseline and post-dose PET scans. Based on the KOR receptor occupancy (RO) results from this cohort, dosing may be explored further in subsequent cohorts.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,691 Total Patients Enrolled

Media Library

CVL-354 (Opioid Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05547542 — Phase 1
Opioid Use Disorder Research Study Groups: Part A: Kappa Opioid Receptor (KOR) Cohort, Part B: Mu Opioid Receptor (MOR) Cohort
Opioid Use Disorder Clinical Trial 2023: CVL-354 Highlights & Side Effects. Trial Name: NCT05547542 — Phase 1
CVL-354 (Opioid Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05547542 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment have an age restriction for participants?

"This specific clinical trial is only open to those within the age range of 18-55. For individuals younger than 18, there are 22 trials available and 241 options for applicants over 65 years old."

Answered by AI

Am I eligible to be a participant in this experiment?

"24 participants are required for this trial, with all candidates needing to possess opioid use disorder (OUD) and a chronological age between 18-55 years."

Answered by AI

What potential perils can be associated with participating in the Part A: Kappa Opioid Receptor (KOR) Cohort?

"The safety of Part A: Kappa Opioid Receptor (KOR) Cohort is estimated to be a 1, given it is only in the earliest phase of clinical trials and has scant evidence regarding its efficacy and security."

Answered by AI

Are there any vacancies left for individuals to participate in this medical trial?

"Based on clinicaltrials.gov, this particular trial is no longer accepting candidates. Initially posted in December of 2022, the study was edited for the last time that same month; however, 292 other studies are currently open to enrollment."

Answered by AI

Who else is applying?

What state do they live in?
Connecticut
What site did they apply to?
Yale PET Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Recent research and studies
clinicaltrials.govStudy
Positron Emission Tomography (PET) Trial to Evaluate Target Occupancy of CVL-354 at Kappa and Mu Opioid Receptors in Brain Following Oral Dosing
2023. "Positron Emission Tomography (PET) Trial to Evaluate Target Occupancy of CVL-354 at Kappa and Mu Opioid Receptors in Brain Following Oral Dosing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05547542.
~2 spots leftby Jun 2024
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