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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
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| 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) |
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| 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) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment A: Emraclidine 30mg IR tablets (reference) | Drug | IR oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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
NOTE: Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overland Park, Kansas | Overland Park | Kansas | 66212 | United States |
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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.
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| Treatment B: Emraclidine 30mg IR test tablets 1 | Drug | IR oral tablets |
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| Treatment C: Emraclidine 30mg IR test tablets 2 | Drug | IR oral tablets |
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| Treatment D: Emraclidine 30mg IR test tablets 3 | Drug | IR oral tablets |
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| 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) |
| Changes in Suicidality as Assessed by 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 approximately 4 months |