Study S003334

A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of ECC5004 on the Single Dose Pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

ClinicalTrials.gov record

Registration

Registration: NCT06293742
Study type: INTERVENTIONAL
Allocation: NON_RANDOMIZED
Phase: PHASE1
Masking: NONE
Status: COMPLETED
Enrollment: 48
Start: 2024-02-08
Primary completion: 2024-04-15
Lead sponsor: Eccogene
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG:ECC5004; DRUG:Midazolam; DRUG:Rosuvastatin; DRUG:Digoxin; DRUG:Atorvastatin
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Atorvastatin PK parameters: AUC(0-tlast) [Part B and optional Part D: up to Day 34]
Atorvastatin PK parameters: AUC(0-inf) [Part B and optional Part D: up to Day 34]
Atorvastatin PK parameters: Cmax [Part B and optional Part D: up to Day 34]
Rosuvastatin PK parameters: AUC(0-tlast) [Part A and optional Part C: up to Day 11]
Rosuvastatin PK parameters: AUC(0-inf) [Part A and optional Part C: up to Day 11]
Rosuvastatin PK parameters: Cmax [Part A and optional Part C: up to Day 11]
Digoxin PK parameters: AUC(0-tlast) [Part A and optional Part C: up to Day 11]
Digoxin PK parameters: AUC(0-inf) [Part A and optional Part C: up to Day 11]
Digoxin PK parameters: Cmax [Part A and optional Part C: up to Day 11]
Midazolam PK parameters: AUC(0-tlast) [Part B and optional Part D: up to Day 34]
Midazolam PK parameters: AUC(0-inf) [Part B and optional Part D: up to Day 34]
Midazolam PK parameters: Cmax [Part B and optional Part D: up to Day 34]

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