protocolSection identificationModule nctId: NCT06342700, orgStudyIdInfo id: PKM18138, secondaryIdInfos id: U1111-1299-1906, type: REGISTRY, domain: ICTRP, briefTitle: A Food Effect and Relative Bioavailability Study of Rilzabrutinib in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-04-29, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Sanofi, class: INDUSTRY, descriptionModule briefSummary: This is a cross-over, Phase 1, 4-arm study. The purpose of this study is to measure the relative bioavailability and food effect of crystalline formulation rilzabrutinib and amorphous formulation rilzabrutinib in healthy male and female participants aged 18 to 55 years of age.The total study duration per participant is expected to be up to 36 days, including:* Screening: up to 4 weeks* Treatment periods: once successfully screened, enrolled participants will be randomized to 1 of 4 treatment sequences with 4 single dose treatment periods.* Washout: One day washout is planned after each treatment period hence providing 2 days between doses.* Safety follow-up: participants will be asked to participate in an end-of-study safety assessment upon discharge from the clinical study unit, ie, on Day 8 of the study., conditionsModule conditions: Autoimmune Disorder, conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 28, type: ESTIMATED, armsInterventionsModule interventions name: Rilzabrutinib crystalline form, interventions name: Rilzabrutinib amorphous form, outcomesModule primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fasted state, primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fasted state, primaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fasted state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib Cmax following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUClast following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Relative bioavailability as assessed by rilzabrutinib AUC following administration of the test and reference formulations in the fed state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib Cmax following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib AUClast following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Food effects as assessed by rilzabrutinib AUC following administration of the test and reference formulations under the fed versus fasted state, secondaryOutcomes measure: Number of participants with adverse events, treatment-emergent adverse events, serious adverse events and adverse events of special interest, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Nucleus Network Site Number : 8400001, status: RECRUITING, city: Saint Paul, state: Minnesota, zip: 55114, country: United States, geoPoint lat: 44.94441, lon: -93.09327, hasResults: False