Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Phase 2
Completed
- Conditions
- GoutHyperuricemia
- Interventions
- Drug: High dose combination
- Registration Number
- NCT01052987
- Lead Sponsor
- Nuon Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Tranilast Tranilast Tranilast tablets Allopurinol Allopurinol Allopurinol tablets Combination Combination - Tranilast and Allopurinol Tranilast plus Allopurinol High dose Allopurinol 400 mg Allopurinol 400 mg Allopurinol High dose combination High dose combination Combination of Tranilast 300 mg and Allopurinol 400 mg
- Primary Outcome Measures
Name Time Method Mean percent decrease in serum uric acid levels Seven days
- Secondary Outcome Measures
Name Time Method Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination Seven days
Trial Locations
- Locations (1)
Nuon Investigative Site
🇺🇸Dallas, Texas, United States