Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia

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

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

Inclusion Criteria:

• Male or female, aged 21 to 70
• Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

• Pregnant or nursing
• Known history of gout unless approved by the Investigator or Sponsor
• Clinically significant infection at Screening
• Known sensitivity to tranilast or allopurinol