NCT02252835

Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Arhalofenate	800 mg once daily orally for four weeks
DRUG	Febuxostat	40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks
DRUG	Arhalofenate	600 mg once daily orally for four weeks
DRUG	Febuxostat	80 mg once daily orally for 1 week then down-titrated to 40 mg once daily orally for another three weeks
DRUG	Colchicine	0.6 mg daily

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-09-30
• Last updated: 2015-04-17

Locations

1 site across 1 country: United States