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

Primary Purpose

Healthy Participants

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment A: Emraclidine 30mg IR tablets (reference)
Treatment B: Emraclidine 30mg IR test tablets 1
Treatment C: Emraclidine 30mg IR test tablets 2
Treatment D: Emraclidine 30mg IR test tablets 3
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Participants

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Overland Park, KansasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1: A-B-C-D

Sequence 2: B-C-D-A

Sequence 3: C-D-A-B

Sequence 4: D-A-B-C

Arm Description

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)

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)

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)

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)

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine

Secondary Outcome Measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Number of Participants With Clinically Significant Changes in Vital Sign Values
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
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.

Full Information

First Posted
June 28, 2023
Last Updated
July 24, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05933187
Brief Title
A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Participants

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
This is a 4-period, 4-sequence crossover study. The 4 treatments are A- 30 milligrams (mg) emraclidine IR tablets (reference); B- 30 mg emraclidine IR test tablets 1; C- 30 mg emraclidine IR test tablets 2; D- 30 mg emraclidine IR test tablets 3. Participants will be randomized to 1 of 4 treatment sequences. Each participant will be administered each of the 4 treatments exactly once, i.e.,1 treatment per period and there will be a 7 day washout period between each treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1: A-B-C-D
Arm Type
Experimental
Arm Description
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)
Arm Title
Sequence 2: B-C-D-A
Arm Type
Experimental
Arm Description
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)
Arm Title
Sequence 3: C-D-A-B
Arm Type
Experimental
Arm Description
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)
Arm Title
Sequence 4: D-A-B-C
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Treatment A: Emraclidine 30mg IR tablets (reference)
Other Intervention Name(s)
CVL-231
Intervention Description
IR oral tablets
Intervention Type
Drug
Intervention Name(s)
Treatment B: Emraclidine 30mg IR test tablets 1
Other Intervention Name(s)
CVL-231
Intervention Description
IR oral tablets
Intervention Type
Drug
Intervention Name(s)
Treatment C: Emraclidine 30mg IR test tablets 2
Other Intervention Name(s)
CVL-231
Intervention Description
IR oral tablets
Intervention Type
Drug
Intervention Name(s)
Treatment D: Emraclidine 30mg IR test tablets 3
Other Intervention Name(s)
CVL-231
Intervention Description
IR oral tablets
Primary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time Frame
Predose and up to 96 hours post dose in each treatment period
Title
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Time Frame
Predose and up to 96 hours post dose in each treatment period
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 4 months
Title
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Time Frame
Up to approximately 4 months
Title
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time Frame
Up to approximately 4 months
Title
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time Frame
Up to approximately 4 months
Title
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time Frame
Screening up to checkout (up to approximately 4 months)
Title
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
Up to approximately 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandi Eckard, Director Recruitment
Phone
(913) 333-3000
Email
beckard@drvince.com
Facility Information:
Facility Name
Overland Park, Kansas
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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