Other
Part A: Emraclidine Followed by Itraconazole + Emraclidine 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
Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator.
Body mass index of 18.5 to 35.0 kilograms per square meter (kg/m^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds [lbs]).
Must not have
Be younger than 18 years old
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom the first dose up to 1 month following last dose with investigational medicinal product (imp) in each part of the study
Awards & highlights
No Placebo-Only Group
Study Summary
This trial studies how medicines interact with each other in healthy adults to see how they affect each other.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
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
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
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 moreSecondary 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Itraconazole
2017
Completed Phase 2
~780
Metformin
2006
Completed Phase 4
~2430
Carbamazepine
2016
Completed Phase 4
~2690
Find a site
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
33 Previous Clinical Trials
5,619 Total Patients Enrolled
Media Library
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