NCT01052987

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Nuon Therapeutics, Inc. · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	Tranilast	Tranilast tablets, 300 mg, QD
DRUG	Allopurinol	Allopurinol tablets 300 mg, QD
DRUG	Combination - Tranilast and Allopurinol	Tranilast, 300 mg QD; Allopurinol 300 mg QD
DRUG	400 mg Allopurinol	400 mg Allopurinol administered once daily for 7 days
DRUG	High dose combination	Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-06-01
• Completion: 2010-11-01
• First posted: 2010-01-21
• Last updated: 2011-01-06

Locations

3 sites across 1 country: United States