NCT06293742

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Eccogene · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consists of four parts (Part A, Part B, optional Part C and optional Part D), each with approximately 16 healthy participants enrolled. Part A and optional Part C of the study will have the same study design with two treatment periods, except that ECC5004 will be administered at a higher dose level in the optional Part C. Part B and optional Part D of the study will have the same study design with five treatment periods, except that ECC5004 will be administered at a higher dose level in optional Part D. Rosuvastatin and Digoxin will be administered alone or in combination with EC5004 in Part A and optional Part C. Atorvastatin and Midazolam will be administered alone or in combination with ECC5004 in Part B and optional Part D. The conduct of Part C and Part D with an increased dose of ECC5004 may be conducted as optional parts.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	ECC5004	ECC5004 tablet will be administered orally.
DRUG	Midazolam	Midazolam will be administered orally.
DRUG	Rosuvastatin	Rosuvastatin will be administered orally.
DRUG	Digoxin	Digoxin will be administered orally.
DRUG	Atorvastatin	Atorvastatin will be administered orally.

Timeline

• Start date: 2024-02-08
• Primary completion: 2024-04-15
• Completion: 2024-04-15
• First posted: 2024-03-05
• Last updated: 2024-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study