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Emraclidine 30 mg for Healthy Subjects

Phase 1
Recruiting
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 16
Awards & highlights

Study Summary

This trial aims to understand how the body processes a drug called emraclidine when taken by mouth, by looking at how much of the drug is eliminated from the body, how it is eliminated,

Who is the study for?
This trial is for healthy adult men who can participate in a study to understand how the body processes and eliminates a drug called Emraclidine after taking it once. Specific eligibility details are not provided, but typically participants must meet certain health standards.Check my eligibility
What is being tested?
The study is testing how Emraclidine, when taken orally by healthy men, moves through the body and is broken down or excreted. It involves measuring the drug's presence in blood and other bodily outputs to understand its behavior.See study design
What are the potential side effects?
Since this trial involves healthy subjects and focuses on pharmacokinetics rather than treatment effects, side effects are not detailed here. However, as with any clinical trial, there may be risks which will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood
Amount Excreted in Feces (Aef) of Total Radioactivity
Amount Excreted in Urine (Aeu) of Total Radioactivity
+20 more
Secondary outcome measures
Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Metabolite Profile of Emraclidine in Plasma, Urine and Feces
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Emraclidine 30 mgExperimental Treatment1 Intervention
Participants will receive a single oral dose of 30 milligrams (mg) (approximately 75 microcurie [μCi]) [14C]-emraclidine on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emraclidine
2023
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
34 Previous Clinical Trials
5,687 Total Patients Enrolled

Frequently Asked Questions

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

What are the potential risks associated with administering a 30 mg dose of Emraclidine to patients?

"Our team at Power assesses the safety of Emraclidine 30 mg to be a level 1 on our scale due to this being a Phase 1 trial, indicating scarce evidence supporting both safety and effectiveness."

Answered by AI

Which individuals are considered more suitable candidates to participate in this scientific investigation?

"Individuals aged between 18 and 55 who are in good health may qualify for inclusion in this trial, which is seeking to enroll approximately 8 participants."

Answered by AI

What is the upper limit of participants involved in this research endeavor?

"Indeed, the details on clinicaltrials.gov highlight that this medical investigation is currently seeking participants. The trial was initially shared on March 1st, 2024 and last revised on March 4th, 2024. They aim to enroll eight subjects from a single site."

Answered by AI

Are individuals who are younger than 20 years of age eligible to participate in this study?

"To be eligible for this research study, candidates must be at least 18 years old but no older than 55."

Answered by AI

Are patients currently eligible to enroll in this research study?

"As per the data available on clinicaltrials.gov, this research study is presently in the recruitment phase. It was first published online on March 1st, 2024 and last revised on March 4th, 2024."

Answered by AI

Who else is applying?

What site did they apply to?
Austin, Texas
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

i like medical trials.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants
2024. "A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06301971.
All > Pflugerville Tx > Paid Studies Austin
~5 spots leftby Apr 2025
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