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Completed

NCT Number: NCT06366243

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dilworth, Minnesota

Dilworth, Minnesota, 56529, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emraclidine

Drug

Oral tablet

Other names: CVL-231

Esomeprazole

Drug

Oral delayed-release capsule

Other names: Nexium

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Time frame: 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

  2. Time to Maximum (Peak) Plasma Concentration (Tmax) of Emraclidine

    Time frame: 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

  3. Area Under the Plasma Concentration-time Curve From Time 0 to the Time of Last Quantifiable Concentration (AUC0-t) of Emraclidine

    Time frame: 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

  4. Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Emraclidine

    Time frame: 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 outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 29 days

  2. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values

    Time frame: Up to 45 days

  3. Number of Participants With Clinically Significant Changes in Vital Sign Parameters

    Time frame: Up to 45 days

  4. Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

    Time frame: Up to 45 days

  5. Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

    Time frame: Up to 45 days

  6. Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to 45 days

    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.

Sponsors and collaborators

Lead sponsor

Cerevel Therapeutics, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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