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Emraclidine (Fasted then Fed) for Healthy Subjects

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 day 13
Awards & highlights

Study Summary

This trial looks at how a high-fat meal affects how a drug is processed in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 13 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
+1 more
Secondary outcome measures
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Number of Participants With Clinically Significant Changes in Laboratory Assessments
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Emraclidine (Fed then Fasted)Experimental Treatment1 Intervention
Single oral dose of Emraclidine 15 mg tablet under fed condition followed by fasted (without food) condition in treatment period 1 and 2, respectively.
Group II: Emraclidine (Fasted then Fed)Experimental Treatment1 Intervention
Single oral dose of Emraclidine 15 mg tablet under fasted (without food) condition followed by fed condition in treatment period 1 and 2, respectively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emraclidine
2024
Completed Phase 1
~90

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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
5,703 Total Patients Enrolled
~8 spots leftby May 2025
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