A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

NCT00995618 Phase 2 COMPLETED

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Details

Lead sponsor	Nuon Therapeutics, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	24
Start date	2009-09
Completion	2010-04

Conditions

• Gout
• Hyperuricemia

Interventions

• Tranilast
• Febuxostat
• Combination - Tranilast and Febuxostat

Primary outcomes

• Mean decrease in serum uric acid levels — Seven days

Countries

United States