Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of [14C]-emraclidine in healthy adult male participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emraclidine 30 mg | Experimental | Participants will receive a single oral dose of 30 milligrams (mg) (approximately 75 microcurie [μCi]) [14C]-emraclidine on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emraclidine | Drug | Oral solution/suspension |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite Profile of Emraclidine in Plasma, Urine and Feces | Pre-dose and at multiple time points post-dose up to Day 15 | |
| Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces | Pre-dose and at multiple time points post-dose up to Day 15 |
Not provided
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.
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.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
U.S. Food and Drug Administration (FDA) recommends that radiation exposure to participants should be kept as low as is reasonably achievable; and since there is no available data to suggest metabolism of the emraclidine is different in women versus men. Hence, female participants are excluded from this study.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin, Texas | Austin | Texas | 78744 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pre-dose and at multiple time points post-dose up to Day 15 |
| Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine | Pre-dose and at multiple time points post-dose up to Day 15 |
| Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine | Pre-dose and at multiple time points post-dose up to Day 15 |
| Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Amount Excreted in Urine (Aeu) of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Cumulative Aeu of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Percentage Excreted in Urine (feu) of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Cumulative feu of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Amount Excreted in Feces (Aef) of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Cumulative Aef of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Percentage Excreted in Feces (fef) of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Cumulative fef of Total Radioactivity | Pre-dose and at multiple time points post-dose up to Day 15 |
| Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined | Pre-dose and at multiple time points post-dose up to Day 15 |
| Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined | Pre-dose and at multiple time points post-dose up to Day 15 |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to Day 16 |
| Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values | Up to Day 15 |
| Number of Participants with Clinically Significant Changes in Vital Signs | Up to Day 15 |
| Number of Participants with Clinically Significant Changes in Laboratory Assessments | Up to Day 15 |
| Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results | Up to Day 15 |
| Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score | 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 Day 15 |