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

Nuon Therapeutics, Inc.24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Gout Hyperuricemia

Interventions

TranilastDRUG

Tranilast tablets, 300 mg, QD

AllopurinolDRUG

Allopurinol tablets 300 mg, QD

Combination - Tranilast and AllopurinolDRUG

Tranilast, 300 mg QD; Allopurinol 300 mg QD

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Nuon Investigative Site

Honolulu, Hawaii, United States

Nuon Investigative Site

Evansville, Indiana, United States

Nuon Investigative Site

Dallas, Texas, United States

Outcomes

Primary Outcomes

Mean percent decrease in serum uric acid levels

Time frame: Seven days

Secondary Outcomes

Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination

Time frame: Seven days

Data from ClinicalTrials.gov

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