Opioid Use DisorderPhase 1NCT05547542
Positron Emission Tomography (PET) Trial to Evaluate Target Occupancy of CVL-354 at Kappa and Mu Opioid Receptors in Brain Following Oral Dosing
A Phase 1 study testing CVL-354, [11C]-LY2795050 and [11C]-carfentanil in people with Opioid Use Disorder, run by Cerevel Therapeutics, LLC at 2 sites in United States.
Trial summary
The primary purpose of this study is to assess the target occupancy at kappa and mu opioid receptors in the brain after single oral doses of CVL-354 in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- CVL-354, [11C]-LY2795050 and [11C]-carfentanil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2023to 6 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women of nonchildbearing potential and men 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
- Body mass index of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening.
- Sexually active men with a pregnant or nonpregnant partner of childbearing potential must agree to comply with the following contraception requirements during the trial and for 7 days after the last dose of investigational medicinal product (IMP):
- Use condom or remain abstinent. In addition, male participants should not donate sperm for a minimum of 7 days following the last dose of IMP.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
Who cannot join
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
- "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
- Suicidal Ideation Item 3 (Active Suicidal Ideation with Any Methods [Not Plan] without Intent to Act)
- Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan)
- Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent)
- Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, Preparatory Acts or Behavior) "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
Show all 20Show fewer
- Suicidal Ideation Item 1 (Wish to be Dead)
- Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary.
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria within 12 months prior to signing the ICF.
- Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, uncomplicated appendectomy, and cholecystectomy.
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing. In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of IMP will be excluded.
- Have recently been diagnosed with symptomatic coronavirus disease-2019 (COVID-19) or test positive (i.e., using polymerase chain reaction (PCR) or rapid antigen test) for COVID-19 within 30 days prior to signing the ICF.
- Use of prohibited medication prior to randomization or likely to require prohibited concomitant therapy (e.g., prescription and over-the-counter medications, herbal medications, vitamins, and supplements) during the trial.
- Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
- Positive drug screen (including cotinine and tetrahydrocannabinol [THC]) or a positive test for alcohol.
- Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 × upper limit of normal (ULN).
- Total bilirubin >1.5 × ULN. If Gilbert's syndrome is suspected, total bilirubin >1.5 × ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin.
- Estimated glomerular filtration rate <90 milliliters per minute (mL/min)/1.73 m^2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 equation at the Screening Visit or Check-in (Day -1).
- Note: Other protocol-defined Exclusion criteria may apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Haven, Connecticut
New Haven, Connecticut, 06510
Yale PET Center
New Haven, Connecticut, 06510
About this study
Official title: A Phase 1, Open-label Trial to Evaluate Target Occupancy of CVL-354 at Kappa Opioid and Mu Opioid Receptors in Brain Following Single Oral Doses in Healthy Participants Using Positron Emission Tomography
The primary purpose of this study is to assess the target occupancy at kappa and mu opioid receptors in the brain after single oral doses of CVL-354 in healthy adult participants.
- Conditions
- Opioid Use Disorder
- Being tested
- CVL-354, [11C]-LY2795050, [11C]-carfentanil
- Keywords
- Healthy adult participants
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-354Drug
Oral solution/capsule
[11C]-LY2795050Drug
IV injection
[11C]-carfentanilDrug
IV injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: Kappa Opioid Receptor (KOR) Cohort | Experimental | 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. Receives: Drug: CVL-354; Drug: [11C]-LY2795050 |
| Part B: Mu Opioid Receptor (MOR) Cohort | Experimental | 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. Receives: Drug: CVL-354; Drug: [11C]-carfentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappa Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Measured: Day 1
Mu Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Measured: Day 1
Secondary outcomes (9)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 18 days
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Measured: Up to Day 2
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Measured: Up to Day 2
Number of Participants Clinically Significant Changes in Clinical Laboratory Assessments
Measured: Up to Day 2
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Measured: Up to Day 2
Number of Participants With Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Measured: Up to Day 2
Maximum Observed Plasma Concentration (Cmax) of CVL-354 During Scan
Measured: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Area Under the Plasma Concentration-time Curve (AUC) of CVL-354 for Scan Duration
Measured: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Average Plasma Concentration (Cavg) of CVL-354 for Scan Duration
Measured: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start2 Mar 2023
- Primary completion24 Jul 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547542
- Sponsor's protocol ID
- CVL-354-1002
- Other IDs
- 4UH3DA052166-02
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2022
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Trial to Evaluate Target Occupancy of CVL-354 at Kappa Opioid and Mu Opioid Receptors in Brain Following Single Oral Doses in Healthy Participants Using Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT05547542
- Acronym / sponsor ID
- CVL-354-1002
- Conditions
- Opioid Use Disorder
- Keywords
- Healthy adult participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 24 Jul 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the target occupancy at kappa and mu opioid receptors in the brain after single oral doses of CVL-354 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Kappa Opioid Receptor (KOR) Cohort | Experimental | Drug: CVL-354, Drug: [11C]-LY2795050Participants 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. |
| Part B: Mu Opioid Receptor (MOR) Cohort | Experimental | Drug: CVL-354, Drug: [11C]-carfentanilPart 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women of nonchildbearing potential and men 18 to 55 years, inclusive, at the time of signing the informed consent form (ICF).
- Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
- Body mass index of 18.5 to 32.0 kilograms per square meter (kg/m^2), inclusive, and total body weight >50 kg (110 pounds [lb]) at Screening.
- Sexually active men with a pregnant or nonpregnant partner of childbearing potential must agree to comply with the following contraception requirements during the trial and for 7 days after the last dose of investigational medicinal product (IMP):
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Key exclusion criteria (20 listed)
- Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
- "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
- History of substance or alcohol-use disorder (excluding nicotine or caffeine) as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria within 12 months prior to signing the ICF.
- Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, uncomplicated appendectomy, and cholecystectomy.
- Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing. In addition, participants who plan to receive SARS-CoV-2 vaccination or booster while participating in the trial or for a minimum of 7 days (to cover at least 5 half-lives of IMP) after the last dose of IMP will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL-354Oral solution/capsule | Drug | Part A: Kappa Opioid Receptor (KOR) Cohort, Part B: Mu Opioid Receptor (MOR) Cohort |
| [11C]-LY2795050IV injection | Drug | Part A: Kappa Opioid Receptor (KOR) Cohort |
| [11C]-carfentanilIV injection | Drug | Part B: Mu Opioid Receptor (MOR) Cohort |
Primary outcome
Kappa Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Time frame: Day 1
Mu Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants
Time frame: Day 1
9 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 18 days
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results
Time frame: Up to Day 2
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to Day 2
Number of Participants Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Up to Day 2
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 2
Number of Participants With Suicidal Ideation and Behavior Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 2
Maximum Observed Plasma Concentration (Cmax) of CVL-354 During Scan
Time frame: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Area Under the Plasma Concentration-time Curve (AUC) of CVL-354 for Scan Duration
Time frame: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Average Plasma Concentration (Cavg) of CVL-354 for Scan Duration
Time frame: Day 1 (1.25, 2.0, and 2.75 hours post dose)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVL-354, [11C]-LY2795050 and [11C]-carfentanil in people with Opioid Use Disorder, run by Cerevel Therapeutics, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kappa Opioid Receptor Occupancy in the Brain Following Single Oral Doses of CVL-354 in Healthy Adult Participants (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.