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Part A: Kappa Opioid Receptor (KOR) Cohort for Opioid Use Disorder

Yale PET Center, New Haven, CT
Opioid Use Disorder[11C]-carfentanil - Drug
Eligibility
18 - 55
All Sexes

Study Summary

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

Eligible Conditions
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

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Study Objectives

2 Primary · 9 Secondary · Reporting Duration: Day 1 (1.25, 2.0, and 2.75 hours post dose)

Day 1
Brain
Mu Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Day 1
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
Up to 18 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Up to Day 2
Number of Participants Clinically Significant Changes in Clinical Laboratory Assessments
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Number of Participants With Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Trial Safety

Phase-Based Safety

1 of 3

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1
Daratumumab / Hyaluronidase Injection
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Part A: Kappa Opioid Receptor (KOR) Cohort
1 of 2
Part B: Mu Opioid Receptor (MOR) Cohort
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Part A: Kappa Opioid Receptor (KOR) Cohort · No Placebo Group · Phase 1

Part A: Kappa Opioid Receptor (KOR) CohortExperimental Group · 2 Interventions: [11C]-LY2795050, CVL-354 · Intervention Types: Drug, Drug
Part B: Mu Opioid Receptor (MOR) CohortExperimental Group · 2 Interventions: [11C]-carfentanil, CVL-354 · Intervention Types: Drug, Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 (1.25, 2.0, and 2.75 hours post dose)

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
27 Previous Clinical Trials
4,831 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Connecticut100.0%
What site did they apply to?
Yale PET Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
2100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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