Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

Nuon Therapeutics, Inc.24 enrolled

Overview

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat 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

FebuxostatDRUG

Febuxostat Tablets, 40 mg, QD

Combination - Tranilast and FebuxostatDRUG

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female, aged 18 to 70 * Subjects with hyperuricemia who are otherwise healthy Exclusion Criteria: * Pregnant or nursing * Known history of gout * Clinically significant infection at Screening * Known sensitivity to tranilast or febuxostat

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 decrease in serum uric acid levels

Time frame: Seven days

Secondary Outcomes

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

Time frame: 7 days

Data from ClinicalTrials.gov

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