The Effect of Food on the Pharmacokinetics (PK) of Emraclidine in Healthy Adult Participants

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

No Placebo-Only Group

Summary

This trial tests how a drug called emraclidine and its byproduct behave when taken with a high-fat meal in healthy adults. Researchers want to see if the meal changes how much of the drug gets into the bloodstream and how quickly it happens.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 13

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~110

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