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

NCT ID: NCT05933187

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-19

Study Completion Date

2023-09-12

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Treatment A: Emraclidine 30mg IR tablets (reference)

Intervention Type DRUG

IR oral tablets

Treatment B: Emraclidine 30mg IR test tablets 1

Intervention Type DRUG

IR oral tablets

Treatment C: Emraclidine 30mg IR test tablets 2

Intervention Type DRUG

IR oral tablets

Treatment D: Emraclidine 30mg IR test tablets 3

Intervention Type DRUG

IR oral tablets

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)

Group Type EXPERIMENTAL

Treatment A: Emraclidine 30mg IR tablets (reference)

Intervention Type DRUG

IR oral tablets

Treatment B: Emraclidine 30mg IR test tablets 1

Intervention Type DRUG

IR oral tablets

Treatment C: Emraclidine 30mg IR test tablets 2

Intervention Type DRUG

IR oral tablets

Treatment D: Emraclidine 30mg IR test tablets 3

Intervention Type DRUG

IR oral tablets

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)

Group Type EXPERIMENTAL

Treatment A: Emraclidine 30mg IR tablets (reference)

Intervention Type DRUG

IR oral tablets

Treatment B: Emraclidine 30mg IR test tablets 1

Intervention Type DRUG

IR oral tablets

Treatment C: Emraclidine 30mg IR test tablets 2

Intervention Type DRUG

IR oral tablets

Treatment D: Emraclidine 30mg IR test tablets 3

Intervention Type DRUG

IR oral tablets

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)

Group Type EXPERIMENTAL

Treatment A: Emraclidine 30mg IR tablets (reference)

Intervention Type DRUG

IR oral tablets

Treatment B: Emraclidine 30mg IR test tablets 1

Intervention Type DRUG

IR oral tablets

Treatment C: Emraclidine 30mg IR test tablets 2

Intervention Type DRUG

IR oral tablets

Treatment D: Emraclidine 30mg IR test tablets 3

Intervention Type DRUG

IR oral tablets

Interventions

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Treatment A: Emraclidine 30mg IR tablets (reference)

IR oral tablets

Intervention Type DRUG

Treatment B: Emraclidine 30mg IR test tablets 1

IR oral tablets

Intervention Type DRUG

Treatment C: Emraclidine 30mg IR test tablets 2

IR oral tablets

Intervention Type DRUG

Treatment D: Emraclidine 30mg IR test tablets 3

IR oral tablets

Intervention Type DRUG

Other Intervention Names

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CVL-231 CVL-231 CVL-231 CVL-231

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Overland Park, Kansas

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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CVL-231-HV-1013

Identifier Type: -

Identifier Source: org_study_id