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

Healthy Participants Clinical Trial

Official title:

A Phase 1, Open-Label, Fixed-Sequence Trial to Evaluate the Effect of Esomeprazole and Gastric pH-Altering on the Pharmacokinetics of Emraclidine in Healthy Adult Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366243
• Other study ID #: CVL-231-HV-1012
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 10, 2024
• Est. completion date: June 24, 2024

Study information

• Verified date: April 2024
• Source: Cerevel Therapeutics, LLC
• Contact: Daniela Barredo
• Email: daniela.barredoescalona[@]ppd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 24, 2024
• Est. primary completion date: June 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Emraclidine
Oral tablet
• Esomeprazole
Oral delayed-release capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Emraclidine		Pre-dose and at multiple time points post-dose on Days 1 to 6 in Period 1 and Days 6 to 11 in Period 2
Primary	Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine		Pre-dose and at multiple time points post-dose on Days 1 to 6 in Period 1 and Days 6 to 11 in Period 2
Primary	Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine		Pre-dose and at multiple time points post-dose on Days 1 to 6 in Period 1 and Days 6 to 11 in Period 2
Primary	Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine		Pre-dose and at multiple time points post-dose on Days 1 to 6 in Period 1 and Days 6 to 11 in Period 2
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)		Up to 29 days
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values		Up to 45 days
Secondary	Number of Participants With Clinically Significant Changes in Vital Sign Parameters		Up to 45 days
Secondary	Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments		Up to 45 days
Secondary	Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results		Up to 45 days
Secondary	Changes in Suicidality Assessed Using 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 45 days