nctId: NCT06301971 id: CVL-231-HV-1011 briefTitle: A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants overallStatus: RECRUITING date: 2024-03 date: 2024-04 date: 2024-04 date: 2024-03-08 date: 2024-03-08 name: Cerevel Therapeutics, LLC class: INDUSTRY briefSummary: 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. conditions: Healthy Participants studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: Emraclidine measure: 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 measure: AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood measure: Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine measure: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine measure: Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity measure: Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine measure: Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity measure: Amount Excreted in Urine (Aeu) of Total Radioactivity measure: Cumulative Aeu of Total Radioactivity measure: Percentage Excreted in Urine (feu) of Total Radioactivity measure: Cumulative feu of Total Radioactivity measure: Amount Excreted in Feces (Aef) of Total Radioactivity measure: Cumulative Aef of Total Radioactivity measure: Percentage Excreted in Feces (fef) of Total Radioactivity measure: Cumulative fef of Total Radioactivity measure: Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined measure: Metabolite Profile of Emraclidine in Plasma, Urine and Feces measure: Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs) measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values measure: Number of Participants with Clinically Significant Changes in Vital Signs measure: Number of Participants with Clinically Significant Changes in Laboratory Assessments measure: Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results measure: Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Austin, Texas status: RECRUITING city: Austin state: Texas zip: 78744 country: United States lat: 30.26715 lon: -97.74306 hasResults: False