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

NCT05933187 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-231-HV-1013
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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)

Study Arms (4)

Sequence 1: A-B-C-D

EXPERIMENTAL

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); 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

Sequence 2: B-C-D-A

EXPERIMENTAL

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); 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

Sequence 3: C-D-A-B

EXPERIMENTAL

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); 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

Sequence 4: D-A-B-C

EXPERIMENTAL

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); 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

Interventions

Treatment A: Emraclidine 30mg IR tablets (reference) DRUG

IR oral tablets

Also known as: CVL-231

Sequence 1: A-B-C-D; Sequence 2: B-C-D-A; Sequence 3: C-D-A-B; Sequence 4: D-A-B-C

Treatment B: Emraclidine 30mg IR test tablets 1 DRUG

IR oral tablets

Also known as: CVL-231

Sequence 1: A-B-C-D; Sequence 2: B-C-D-A; Sequence 3: C-D-A-B; Sequence 4: D-A-B-C

Treatment C: Emraclidine 30mg IR test tablets 2 DRUG

IR oral tablets

Also known as: CVL-231

Sequence 1: A-B-C-D; Sequence 2: B-C-D-A; Sequence 3: C-D-A-B; Sequence 4: D-A-B-C

Treatment D: Emraclidine 30mg IR test tablets 3 DRUG

IR oral tablets

Also known as: CVL-231

Sequence 1: A-B-C-D; Sequence 2: B-C-D-A; Sequence 3: C-D-A-B; Sequence 4: D-A-B-C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (1)

Overland Park, Kansas

Overland Park, Kansas, 66212, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: July 19, 2023
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)