NCT00995618

Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nuon Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Tranilast	Tranilast tablets, 300 mg, QD
DRUG	Febuxostat	Febuxostat Tablets, 40 mg, QD
DRUG	Combination - Tranilast and Febuxostat	Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-10-15
• Last updated: 2011-01-06

Locations

3 sites across 1 country: United States