A Trial to Evaluate the Effect of Esomeprazole on the Pharmacokinetics of Emraclidine in Healthy Adult Participants

NCT ID: NCT06366243

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-10
• Study Completion Date: 2024-06-20

Brief Summary

The primary purpose of this study is to evaluate the potential of gastric pH-dependent drug-drug interaction effect of esomeprazole, a proton pump inhibitor (PPI), on the pharmacokinetics (PK) of emraclidine in healthy adult participants.

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emraclidine 30 mg + Esomeprazole 40 mg

Participants will receive a single oral dose of 30 milligrams (mg) emraclidine on Day 1 of Treatment Period 1. After 6 days following the single dose of emraclidine in Treatment Period 1, participants will receive 40 mg esomeprazole, orally, once daily (QD) on Days 1 to 5 of Treatment Period 2. On Day 6 of Period 2, participants will receive 40 mg esomeprazole followed by a single oral dose of 30 mg emraclidine.

Group Type: EXPERIMENTAL

Emraclidine

Intervention Type: DRUG

Oral tablet

Esomeprazole

Intervention Type: DRUG

Oral delayed-release capsule

Interventions

Emraclidine

Oral tablet

Intervention Type: DRUG

Esomeprazole

Oral delayed-release capsule

Intervention Type: DRUG

Other Intervention Names

CVL-231; Nexium

Eligibility Criteria

Inclusion Criteria

• Sexually active women of childbearing potential must agree to use at least a highly effective 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 per meter square (kg/m2), inclusive, and a total body weight ≥50 kg (110 [pounds] lbs).
• Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECGs, vital sign measurements, and laboratory test results, as evaluated by the investigator.

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, Preparatory Acts or 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)
• 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.
• Use of any prescription and over-the-counter medications from 28 days prior to first dose of IMP or likely to require concomitant therapy. Vaccinations or boosters within 28 days of planned dosing or while on trial are prohibited.
• 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.
• Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary:

• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2× upper limit of normal (ULN).
• Total bilirubin >1.5×ULN. If Gilbert's syndrome is suspected, total bilirubin >1.5×ULN is acceptable if the conjugated or direct bilirubin fraction is <20% of total bilirubin.
• Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
• Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test result at Check-in.
• 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

Cerevel Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Dilworth, Minnesota

Dilworth, Minnesota, United States

Countries

United States

Other Identifiers

CVL-231-HV-1012

Identifier Type: -

Identifier Source: org_study_id