Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT02252835
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2014-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
Sponsor:
Gilead Sciences
Organization:
Study Overview
Official Title:
A Phase 2, Open-label, Drug-Drug Interaction Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination With Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.
Detailed Description:
Patients entering the six-week Treatment Period will receive once daily oral dosing of arhalofenate during Weeks 1 and 2 (Days 1 through 14), combined once daily oral dosing of arhalofenate and febuxostat during Weeks 3 and 4 (Days 15 through 28), and once daily oral dosing of febuxostat during Weeks 5 and 6 (Days 29 through 42). In addition, all patients will receive once daily oral dosing of colchicine throughout the Treatment Period.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: