Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268145
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2024-02-13
Brief Title:
ECC5004 RBA FE Study in Healthy Participants
Sponsor:
Eccogene
Organization:
Eccogene
Study Overview
Official Title:
An Open-Label Randomized Single Dose Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation F1 Compared to New Tablet Formulation F2 of ECC5004 and Food Effects on F1 and F2 of ECC5004 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 study is a Phase 1 open-label randomized single dose fixed sequence crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation F1 and 50 mg ECC5004 new tablet formulation F2 under fasted and fed conditions in healthy participants
Detailed Description:
Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods In the first two treatment periods under fasted conditions participants will fast for a minimum of 10 hours then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2 In the subsequent third and fourth treatment periods under fed conditions participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2
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