protocolSection identificationModule nctId: NCT06389955, orgStudyIdInfo id: TP-3654-103, briefTitle: Assessment of Relative Bioavailability and Effect of Food on Capsule and Tablet Formulations of TP-3654, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-05-22, primaryCompletionDateStruct date: 2023-08-01, completionDateStruct date: 2023-08-24, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Sumitomo Pharma America, Inc., class: INDUSTRY, descriptionModule briefSummary: This study comprised of 2 parts, Part A and Part B. Part B will only be conducted if the relative bioavailability of the tablet formulation was at least 70% of the capsule formulation., conditionsModule conditions: Effect of Drug, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ACTUAL, armsInterventionsModule interventions name: TP 3654, outcomesModule primaryOutcomes measure: Part A - The maximum concentration (Cmax) of TP-3654 in a capsule formulation, primaryOutcomes measure: Part A - The area under the curve (AUC) of TP-3654 in a capsule formulation, primaryOutcomes measure: Part A - Ratio of Peak Plasma Concentration (Cmax) of TP-3654 tablet versus TP-3654 capsule under fasted conditions, primaryOutcomes measure: Part B - The maximum concentration (Cmax) of TP-3654 in a tablet formulation, secondaryOutcomes measure: Number of participants with Treatment Emergent Adverse Events (TEAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Frontage Investigative Site, city: Secaucus, state: New Jersey, zip: 07094, country: United States, geoPoint lat: 40.78955, lon: -74.05653, hasResults: False