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

Gout Clinical Trial

Official title:

A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995618
• Other study ID #: A3006GT
• Status: Completed
• Phase: Phase 2
• First received: October 6, 2009
• Last updated: January 5, 2011
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2011
• Source: Nuon Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• Tranilast
Tranilast tablets, 300 mg, QD
• Febuxostat
Febuxostat Tablets, 40 mg, QD
• Combination - Tranilast and Febuxostat
Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Locations

Country	Name	City	State
United States	Nuon Investigative Site	Dallas	Texas
United States	Nuon Investigative Site	Evansville	Indiana
United States	Nuon Investigative Site	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Nuon Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean decrease in serum uric acid levels		Seven days	No
Secondary	Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination		7 days	No