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30 mg CVL-231 Target Release, Fasted for Schizophrenia

Phase 1
Waitlist Available
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 up to 72 hours in each period
Awards & highlights

Summary

This study is evaluating whether a new formulation of CVL-231 can be taken with or without food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours in each period
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours in each period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Part A & B: Area under the plasma concentration-time curve from time 0 to the last measurable time point (AUClast) for CVL-231 and Metabolite (CV-0000364)
Primary Part A & B: Area under the plasma concentration-time curve from time zero to infinity (AUCinf) for CVL-231 and Metabolite (CV-0000364)
Primary Part A & B: Elimination half-life (t½) for CVL-231 and Metabolite (CV-0000364)
+6 more
Secondary outcome measures
Secondary: Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Secondary: Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Secondary: Incidence of clinically significant changes in clinical laboratory results
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: Single doses of CVL-231 target release formulation under fasted and fed conditionsExperimental Treatment2 Interventions
Oral Dose
Group II: Part A: Single doses of CVL-231 IR/MR formulations in healthy participants under fasted conditionsExperimental Treatment4 Interventions
Oral Dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
30 mg CVL-231 as slow-release MR formulation
2021
Completed Phase 1
~20
30 mg CVL-231 Target Release, Fasted
2021
Completed Phase 1
~20
10 mg CVL-231 as IR formulation
2021
Completed Phase 1
~20
30 mg CVL-231 as fast release MR formulation
2021
Completed Phase 1
~20
30 mg CVL-231 as medium release MR formulation
2021
Completed Phase 1
~20
30 mg CVL-231 Target Release, Fed
2021
Completed Phase 1
~20

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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
36 Previous Clinical Trials
5,696 Total Patients Enrolled
7 Trials studying Schizophrenia
2,010 Patients Enrolled for Schizophrenia
Matthew Leoni, MD, MBAStudy DirectorCerevel Therapeutics, LLC
2 Previous Clinical Trials
88 Total Patients Enrolled
1 Trials studying Schizophrenia
15 Patients Enrolled for Schizophrenia
~5 spots leftby Jul 2025
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