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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 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

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

2023

Completed Phase 1

~80

Do I qualify?Apply below to find out

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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

5,699 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Emraclidine for treatment in a fasted then fed regimen?

"Taking into account the limited safety and efficacy data available, our team has assessed Emraclidine (Fasted then Fed) to have a score of 1."

Answered by AI

Are geriatric patients eligible for this trial?

"The qualifications for this clinical trial are provided on its inclusion criteria - those aged 18 to 55. In contrast, there are 55 studies available for minors and 369 trials tailored specifically towards adults over 65 years of age."

Answered by AI

What is the aggregate figure of participants in this clinical assessment?

"Affirmative, according to clinicaltrials.gov this trial is still enrolling patients. The initial posting date was July 6th 2023 and the most recent update occurred on the 10th of that same month. This research seeks a total of 20 volunteers from a single medical centre."

Answered by AI

Is enrollment for this research still available to eligible volunteers?

"According to official documents found on clinicaltrials.gov, enrollment in this medical trial is ongoing and was initially launched on July 6th 2023 with its most recent update occurring 4 days later."

Answered by AI

Do I meet the requirements to join in this experimentation?

"This clinical trial is currently enrolling 20 people between 18 and 55 with healthy backgrounds. The necessary criteria for enrollment include being a male or female of childbearing or non-childbearing potential, having a progestogen-only oral contraceptive, using male/female condoms with spermicide, falling within the body mass index range of 17.5 to 32 kg/m^2 and weighing more than 45kg (110 lb), possessing general health and capability of understanding the protocol requirements as evaluated by an investigator, providing signed informed consent that adheres to listed restrictions in ICF documents."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "The Effect of Food on the Pharmacokinetics (PK) of Emraclidine in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05915546.

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