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

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: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Treatment A: Emraclidine 30mg IR tablets (reference); Drug: Treatment B: Emraclidine 30mg IR test tablets 1; Drug: Treatment C: Emraclidine 30mg IR test tablets 2; Drug: Treatment D: Emraclidine 30mg IR test tablets 3

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Emraclidine	Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine	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	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	Predose and up to 96 hours post dose in each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to approximately 4 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results		Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Vital Sign Values		Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments		Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results		Screening up to checkout (up to approximately 4 months)
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.	Up to approximately 4 months

Collaborators and Investigators

• Sponsor: Cerevel Therapeutics, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): October 1, 2023

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID 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