protocolSection identificationModule nctId: NCT06342596, orgStudyIdInfo id: 18597, secondaryIdInfos id: J2O-MC-EKBD, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Carbon-14-Labelled [14C] LY3473329 in Healthy Male Participants, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-03-05, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively., conditionsModule conditions: Healthy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-LY3473329, interventions name: [14C]-LY3473329, interventions name: LY3473329, outcomesModule primaryOutcomes measure: Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, primaryOutcomes measure: Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered, primaryOutcomes measure: Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329, secondaryOutcomes measure: Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity, secondaryOutcomes measure: Part 1: PK: Maximum Concentration (Cmax) of LY3473329, secondaryOutcomes measure: Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity, secondaryOutcomes measure: Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable), secondaryOutcomes measure: Part 1: Total Number of Metabolites of LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of [14C]-LY3473329, secondaryOutcomes measure: Part 2: PK: AUC (0-∞) of Total Radioactivity, secondaryOutcomes measure: Part 2: PK: Cmax of LY3473329, secondaryOutcomes measure: Part 2: PK: Cmax of [14C]-LY3473329, secondaryOutcomes measure: Part 2: PK: Cmax of Total Radioactivity, secondaryOutcomes measure: Part 2: Total Radioactivity Recovered in Urine and Feces, eligibilityModule sex: MALE, minimumAge: 35 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea Clinical Research Unit, city: Holbeck, state: Leeds, zip: LS11 9EH, country: United Kingdom, geoPoint lat: 53.25, lon: -1.18333, hasResults: False