nctId: NCT06293742 id: EC0007 briefTitle: ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants overallStatus: RECRUITING date: 2024-02-09 date: 2024-04-19 date: 2024-04-19 date: 2024-03-05 date: 2024-03-05 name: Eccogene class: INDUSTRY 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. conditions: Type 2 Diabetes Mellitus studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: CROSSOVER primaryPurpose: TREATMENT masking: NONE count: 64 type: ESTIMATED name: ECC5004 name: Midazolam name: Rosuvastatin name: Digoxin name: Atorvastatin measure: Atorvastatin PK parameters: AUC(0-tlast) measure: Atorvastatin PK parameters: AUC(0-inf) measure: Atorvastatin PK parameters: Cmax measure: Rosuvastatin PK parameters: AUC(0-tlast) measure: Rosuvastatin PK parameters: AUC(0-inf) measure: Rosuvastatin PK parameters: Cmax measure: Digoxin PK parameters: AUC(0-tlast) measure: Digoxin PK parameters: AUC(0-inf) measure: Digoxin PK parameters: Cmax measure: Midazolam PK parameters: AUC(0-tlast) measure: Midazolam PK parameters: AUC(0-inf) measure: Midazolam PK parameters: Cmax measure: ECC5004 Safety parameters: Number of participants with adverse events (AEs) measure: ECC5004 Safety parameters: Number of participants with vital sign abnormalities measure: ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: ECC5004 Safety parameters: Number of participants with physical examination abnormalities measure: ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities measure: Atorvastatin safety parameters: Number of participants with adverse events (AEs) measure: Atorvastatin safety parameters: Number of participants with vital sign abnormalities measure: Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) measure: Atorvastatin safety parameters: Number of participants with physical examination abnormalities measure: Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Rosuvastatin safety parameters: Number of participants with adverse events (AEs) measure: Rosuvastatin safety parameters: Number of participants with vital sign abnormalities measure: Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Rosuvastatin safety parameters: Number of participants with physical examination abnormalities measure: Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities measure: Digoxin safety parameters: Number of participants with adverse events (AEs) measure: Digoxin safety parameters: Number of participants with vital sign abnormalities measure: Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Digoxin safety parameters: Number of participants with physical examination abnormalities measure: Digoxin safety parameters: Number of participants with clinical laboratory abnormalities measure: Midazolam safety parameters: Number of participants with adverse events (AEs) measure: Midazolam safety parameters: Number of participants with vital sign abnormalities measure: Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities measure: Midazolam safety parameters: Number of participants with physical examination abnormalities measure: Midazolam safety parameters: Number of participants with clinical laboratory abnormalities measure: ECC5004 PK parameters: AUC (0-τ) measure: ECC5004 PK parameters: AUC(0-24) measure: ECC5004 PK parameters: tmax measure: ECC5004 PK parameters: t1/2 measure: ECC5004 PK parameters: CL/F measure: ECC5004 PK parameters: Ctau sex: ALL minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Eccogene Investigational Site status: RECRUITING city: Anaheim state: California zip: 92801 country: United States name: Eccogene role: CONTACT lat: 33.83529 lon: -117.9145 hasResults: False