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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral solution/suspension
Austin, Texas
Austin, Texas, United States
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
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Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Amount Excreted in Urine (Aeu) of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Cumulative Aeu of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Percentage Excreted in Urine (feu) of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Cumulative feu of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Amount Excreted in Feces (Aef) of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Cumulative Aef of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Percentage Excreted in Feces (fef) of Total Radioactivity
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Cumulative fef of Total Radioactivity
Time frame: 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
Time frame: 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
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Metabolite Profile of Emraclidine in Plasma, Urine and Feces
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces
Time frame: Pre-dose and at multiple time points post-dose up to Day 15
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 16
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Laboratory Assessments
Time frame: Up to Day 15
Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: 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.
Time frame: Up to Day 15