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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emraclidine 30 mg + Esomeprazole 40 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 29 days | |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | Up to 45 days | |
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Inclusion Criteria:
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):
"Yes" responses for any of the following items on the C-SSRS (within past 12 months):
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dilworth, Minnesota | Dilworth | Minnesota | 56529 | United States |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Esomeprazole | Drug | Oral delayed-release capsule |
|
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| Number of Participants With Clinically Significant Changes in Vital Sign Parameters |
| Up to 45 days |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments | Up to 45 days |
| Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results | Up to 45 days |
| 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 |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |