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