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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Drug: Tranilast
* Drug: Allopurinol
* Drug: Combination - Tranilast and Allopurinol
* Drug: 400 mg Allopurinol
* Drug: High dose combination


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranilast<br>Tranilast tablets | Drug: Tranilast<br>* Tranilast tablets, 300 mg, QD<br>|
| Active Comparator: Allopurinol<br>Allopurinol tablets | Drug: Allopurinol<br>* Allopurinol tablets 300 mg, QD<br>|
| Experimental: Combination<br>Tranilast plus Allopurinol | Drug: Combination - Tranilast and Allopurinol<br>* Tranilast, 300 mg QD; Allopurinol 300 mg QD<br>|
| Active Comparator: High dose Allopurinol<br>400 mg Allopurinol | Drug: 400 mg Allopurinol<br>* 400 mg Allopurinol administered once daily for 7 days<br>|
| Experimental: High dose combination<br>Combination of Tranilast 300 mg and Allopurinol 400 mg | Drug: High dose combination<br>* Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent decrease in serum uric acid levels |  | Seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination |  | Seven days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Hyperuricemia