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Drug Interactions with Emraclidine in 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 from the first dose up to 1 month following last dose with investigational medicinal product (imp) in each part of the study
Awards & highlights

Study Summary

This trial studies how medicines interact with each other in healthy adults to see how they affect each other.

Who is the study for?
This trial is for healthy adults aged 18-55 with a BMI of 18.5 to 35 kg/m^2 and weight over 50 kg. Participants must be medically stable, including normal ECGs and lab tests. Women must not be able to bear children, and all participants should agree to use contraception.Check my eligibility
What is being tested?
The study examines how Itraconazole affects Emraclidine's presence in the body (Part A), how Carbamazepine influences it (Part B), and how Emraclidine impacts Metformin levels (Part C). It's designed in three parts, each testing different drug interactions in healthy people.See study design
What are the potential side effects?
Potential side effects may include issues related to the digestive system from Metformin; headaches or dizziness from Emraclidine; liver enzyme changes due to Itraconazole; or possible mood alterations with Carbamazepine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose up to 1 month following last dose with investigational medicinal product (imp) in each part of the study
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose up to 1 month following last dose with investigational medicinal product (imp) in each part of the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Part A: Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Part A: Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
+6 more
Secondary outcome measures
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Number of Participants With Clinically Significant Changes in Laboratory Assessments
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: Metformin Followed by Emraclidine + MetforminExperimental Treatment2 Interventions
Participants will receive a single oral dose of metformin 850 mg on Day 1 in TP 1 followed by emraclidine 30 mg, orally, QD for Days 1 to 10, with a single oral dose of metformin 850 mg co-administered on Day 8 in TP 2.
Group II: Part B: Emraclidine Followed by Carbamazepine + EmraclidineExperimental Treatment2 Interventions
Participants will receive a single oral dose of emraclidine 30 mg on Day 1 in TP 1 followed by carbamazepine 100 mg BID from Days 1 to 3, 200 mg BID from Days 4 to 6, and 300 mg BID from Days 7 to 19, orally, with a single oral dose of emraclidine 30 mg on Day 16 in TP 2.
Group III: Part A: Emraclidine Followed by Itraconazole + EmraclidineExperimental Treatment2 Interventions
Participants will receive a single oral dose of emraclidine 10 milligrams (mg) on Day 1 in Treatment Period (TP) 1 followed by itraconazole 200 mg, orally, twice daily (BID) on Day 1 and once daily (QD) from Days 2 to 14, with a single oral dose of emraclidine 10 mg co-administered on Day 5 in TP 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emraclidine
2023
Completed Phase 1
~80
Itraconazole
2017
Completed Phase 2
~780
Metformin
2006
Completed Phase 4
~2430
Carbamazepine
2016
Completed Phase 4
~2690

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
35 Previous Clinical Trials
5,655 Total Patients Enrolled

Media Library

Emraclidine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05965219 — Phase 1
Healthy Subjects Research Study Groups: Part A: Emraclidine Followed by Itraconazole + Emraclidine, Part B: Emraclidine Followed by Carbamazepine + Emraclidine, Part C: Metformin Followed by Emraclidine + Metformin
Healthy Subjects Clinical Trial 2023: Emraclidine Highlights & Side Effects. Trial Name: NCT05965219 — Phase 1
Emraclidine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05965219 — Phase 1

Frequently Asked Questions

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

How many participants are being observed in this investigation?

"Affirmative. As per clinicaltrials.gov, this scientific experiment is still searching for participants and has been since July 21st 2023. The project seeks to recruit 60 patients from one medical site."

Answered by AI

Is there an opportunity to join this research endeavor presently?

"Affirmative, clinicaltrials.gov shows that recruitment for this trial is in progress. It was first posted on July 21st 2023 and last modified a day later; 60 participants need to be sourced from one location."

Answered by AI

Can those younger than sixty years of age participate in this research?

"This research study is only open to those aged 18-55. However, there are 53 studies available for minors and 374 trials accessible to seniors."

Answered by AI

What criteria must be satisfied for individuals to partake in this medical experiment?

"For qualification, applicants must possess a healthy physique and have reached the age of consent but not exceeded 55 years old. This investigation requires 60 total participants."

Answered by AI

To what extent is Part A: Emraclidine Followed by Itraconazole + Emraclidine deemed a safe course of treatment for individuals?

"Our team at Power believes that Part A: Emraclidine Followed by Itraconazole + Emraclidine holds a safety rating of 1 according to our scale, as this is only a Phase 1 trial and there is minimal evidence for effectiveness or risk management."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants
2023. "A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05965219.
~36 spots leftby Apr 2025
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