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

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.

Inclusion Criteria:

• Male or female, aged 18 to 70
• Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

• Pregnant or nursing
• Known history of gout
• Clinically significant infection at Screening
• Known sensitivity to tranilast or febuxostat