protocolSection identificationModule nctId: NCT06293742, orgStudyIdInfo id: EC0007, briefTitle: ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-09, primaryCompletionDateStruct date: 2024-04-19, completionDateStruct date: 2024-04-19, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Eccogene, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants., conditionsModule conditions: Type 2 Diabetes Mellitus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: ECC5004, interventions name: Midazolam, interventions name: Rosuvastatin, interventions name: Digoxin, interventions name: Atorvastatin, outcomesModule primaryOutcomes measure: Atorvastatin PK parameters: AUC(0-tlast), primaryOutcomes measure: Atorvastatin PK parameters: AUC(0-inf), primaryOutcomes measure: Atorvastatin PK parameters: Cmax, primaryOutcomes measure: Rosuvastatin PK parameters: AUC(0-tlast), primaryOutcomes measure: Rosuvastatin PK parameters: AUC(0-inf), primaryOutcomes measure: Rosuvastatin PK parameters: Cmax, primaryOutcomes measure: Digoxin PK parameters: AUC(0-tlast), primaryOutcomes measure: Digoxin PK parameters: AUC(0-inf), primaryOutcomes measure: Digoxin PK parameters: Cmax, primaryOutcomes measure: Midazolam PK parameters: AUC(0-tlast), primaryOutcomes measure: Midazolam PK parameters: AUC(0-inf), primaryOutcomes measure: Midazolam PK parameters: Cmax, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG), secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Digoxin safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Digoxin safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with adverse events (AEs), secondaryOutcomes measure: Midazolam safety parameters: Number of participants with vital sign abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with physical examination abnormalities, secondaryOutcomes measure: Midazolam safety parameters: Number of participants with clinical laboratory abnormalities, secondaryOutcomes measure: ECC5004 PK parameters: AUC (0-τ), secondaryOutcomes measure: ECC5004 PK parameters: AUC(0-24), secondaryOutcomes measure: ECC5004 PK parameters: tmax, secondaryOutcomes measure: ECC5004 PK parameters: t1/2, secondaryOutcomes measure: ECC5004 PK parameters: CL/F, secondaryOutcomes measure: ECC5004 PK parameters: Ctau, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Eccogene Investigational Site, status: RECRUITING, city: Anaheim, state: California, zip: 92801, country: United States, contacts name: Eccogene, role: CONTACT, geoPoint lat: 33.83529, lon: -117.9145, hasResults: False