PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral Dosing

Recruiting at 1 trial location

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Cerevel Therapeutics, LLC

Disqualifiers: Cardiovascular, Psychiatric, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how CVL-231, a drug targeting brain receptors, works in healthy adults. The goal is to understand its effects on specific brain areas before using it to treat schizophrenia.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research Team

Matthew Leoni, MD, MBA

Principal Investigator

Cerevel Therapeutics, LLC

Eligibility Criteria

Inclusion Criteria

Capable of providing informed consent and following study requirements

Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 55 years, inclusive, at the time of signing the ICF

Sexually active men with a pregnant or a nonpregnant partner of childbearing potential must agree to use a double-barrier method of birth control, including a condom, and practice contraception during treatment and through 7 days post dose

Exclusion Criteria

You have used any tobacco or nicotine products in the past month.

Subjects with a 12-lead ECG demonstrating either of the following (average of 3 ECGs obtained at the Screening Visit): QT interval corrected for heart rate using Fridericia's formula >450 msec, Left ventricular hypertrophy, Orthostatic hypotension, which is defined as a decrease of ≥20 mmHg in systolic blood pressure and/or a decrease of ≥10 mmHg in diastolic blood pressure after at least 3 minutes of standing compared with the immediately previous supine/semi-recumbent blood pressure at Screening or at the prescan time point prior to baseline PET scan.

Subjects with a current or past personal history of any psychiatric disorder as classified by DSM-5 criteria or immediate family members with any psychiatric disorder as classified by DSM-5 criteria that require treatment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of CVL-231 and undergo PET scans to evaluate M4 receptor occupancy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including suicidality assessment

10 days

2 visits (in-person)

Treatment Details

Interventions

• CVL-231

Participant Groups

Group I: CVL-231 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Cerevel Therapeutics, LLC

Lead Sponsor

Trials

37

Recruited

5,500+