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NCT06293742Recruiting

ECC5004 DDI Study With Atorvastatin, Rosuvastatin, Digoxin and Midazolam in Healthy Participants

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
EccogenePhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Type 2 Diabetes Mellitus
Drug/Device/Intervention
ECC5004
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Eccogene
Location
Anaheim, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Feb 09, 2024
End date
Apr 19, 2024
Enrollment
64 participants
Primary outcome

Atorvastatin PK parameters: AUC(0-tlast),Atorvastatin PK parameters: AUC(0-inf),Atorvastatin PK parameters: Cmax,Rosuvastatin PK parameters: AUC(0-tlast),Rosuvastatin PK parameters: AUC(0-inf),Rosuvastatin PK parameters: Cmax,Digoxin PK parameters: AUC(0-tlast),Digoxin PK parameters: AUC(0-inf),Digoxin PK parameters: Cmax,Midazolam PK parameters: AUC(0-tlast),Midazolam PK parameters: AUC(0-inf),Midazolam PK parameters: Cmax

Summary

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.

ICD-10 classifications
Type 2 diabetes mellitusType 2 diabetes mellitus with unspecified complicationsType 2 diabetes mellitus with other specified complicationsType 2 diabetes mellitus without complicationsType 2 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06293742
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06293742 through Pure Global AI's free database. This Phase 1 trial is sponsored by Eccogene and is currently Recruiting. The study focuses on Type 2 Diabetes Mellitus. Target enrollment is 64 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.