A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants

July 24, 2023 updated by: Cerevel Therapeutics, LLC

A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Relative Bioavailability of Emraclidine Following a Single Oral Administration of Immediate-Release Tablets in Healthy Adult Participants

The purpose of this trial is to evaluate plasma concentrations of emraclidine following single dose oral administration of different emraclidine immediate release (IR) tablets in healthy participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Brandi Eckard, Director Recruitment
  • Phone Number: (913) 333-3000
  • Email: beckard@drvince.com

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • Overland Park, Kansas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Sexually active women of childbearing potential must agree to use at least an acceptable birth control method, during the trial and for 7 days after the last dose of investigational medicinal product (IMP)
  • Body mass index of 18.5 to 35.0 kilogram/meter square (kg/m^2), inclusive, and a total body weight ≥50 kg
  • 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
  • Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures

Exclusion Criteria:

  • Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial

  • "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):

    • Suicidal Ideation Item 3 (Active Suicidal Ideation With Any Methods [Not Plan] Without Intent to Act)
    • Suicidal Ideation Item 4 (Active Suicidal Ideation With Some Intent to Act, Without Specific Plan)
    • Suicidal Ideation Item 5 (Active Suicidal Ideation With Specific Plan and Intent)
    • Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, or Preparatory Acts/Behavior)

  • "Yes" responses for any of the following items on the C-SSRS (within past 12 months):

    • Suicidal Ideation Item 1 (Wish to be Dead)
    • Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary
  • Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy
  • Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at screening
  • Positive drug screen (including cotinine and tetrahydrocannabinol (THC)) or a positive test for alcohol
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP
  • Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients
  • Received IMP in a clinical trial of emraclidine

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1: A-B-C-D
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence A-B-C-D orally, on Day 1 of each 5-day treatment period (up to 26 days)
Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment B: Emraclidine 30mg IR test tablets 1
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment C: Emraclidine 30mg IR test tablets 2
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment D: Emraclidine 30mg IR test tablets 3
IR oral tablets
Other Names:
  • CVL-231
Experimental: Sequence 2: B-C-D-A
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence B-C-D-A orally, on Day 1 of each 5-day treatment period (up to 26 days)
Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment B: Emraclidine 30mg IR test tablets 1
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment C: Emraclidine 30mg IR test tablets 2
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment D: Emraclidine 30mg IR test tablets 3
IR oral tablets
Other Names:
  • CVL-231
Experimental: Sequence 3: C-D-A-B
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence C-D-A-B orally, on Day 1 of each 5-day treatment period (up to 26 days)
Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment B: Emraclidine 30mg IR test tablets 1
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment C: Emraclidine 30mg IR test tablets 2
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment D: Emraclidine 30mg IR test tablets 3
IR oral tablets
Other Names:
  • CVL-231
Experimental: Sequence 4: D-A-B-C
Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence D-A-B-C orally, on Day 1 of each 5-day treatment period (up to 26 days)
Drug: Treatment A: Emraclidine 30mg IR tablets (reference)
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment B: Emraclidine 30mg IR test tablets 1
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment C: Emraclidine 30mg IR test tablets 2
IR oral tablets
Other Names:
  • CVL-231
Drug: Treatment D: Emraclidine 30mg IR test tablets 3
IR oral tablets
Other Names:
  • CVL-231

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
Time Frame: Predose and up to 96 hours post dose in each treatment period
Predose and up to 96 hours post dose in each treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time Frame: Up to approximately 4 months
Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame: Screening up to checkout (up to approximately 4 months)
Screening up to checkout (up to approximately 4 months)
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to approximately 4 months
The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.
Up to approximately 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cerevel Therapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CVL-231-HV-1013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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