Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783753
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2021-03-02
Brief Title:
Drug-Drug Interaction Study Between EDP-514 Itraconazole Carbamazepine and Quinidine in Healthy Subjects
Sponsor:
Enanta Pharmaceuticals Inc
Organization:
Enanta Pharmaceuticals Inc
Study Overview
Official Title:
A Non-Randomized Open-Label Three-Part Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole Carbamazepine and Quinidine on the Pharmacokinetics and Safety of EDP-514 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Non-randomized 3-part open-label drug-drug interaction DDI study to evaluate the effect of itraconazole carbamazepine or quinidine on the PK and safety of EDP-514 in healthy adult subjects
Detailed Description:
None
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