Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06293742
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Brief Title:
ECC5004 DDI Study With Atorvastatin Rosuvastatin Digoxin and Midazolam in Healthy Participants
Sponsor:
Eccogene
Organization:
Eccogene
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None