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

Phase 2 Completed 32 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2014-08
Primary completion: 2014-12
Completion: 2014-12

Publications

Steinberg AS, Vince BD, Choi YJ, Martin RL, McWherter CA, Boudes PF. The Pharmacodynamics, Pharmacokinetics, and Safety of Arhalofenate in Combination with Febuxostat When Treating Hyperuricemia Associated with Gout. J Rheumatol. 2017 Mar;44(3):374-379. doi: 10.3899/jrheum.161062. Epub 2016 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Arhalofenate	Unknown	600 mg	Oral
Subject	Arhalofenate	Unknown	800 mg	Oral
Subject	Febuxostat	Small molecule	40 mg	Oral
Subject	Febuxostat	Small molecule	80 mg	Oral
Background	Colchicine	Small molecule	0.6 mg	Oral

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

Summary

Timeline

Publications

Drugs

Indications