RDEA3170 and Febuxostat Combination Study in Gout Subjects

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Febuxostat; Verinurad

Criteria

Inclusion Criteria:

• Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity.

• Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.

• Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2.

• Screening serum urate level ≥ 8 mg/dL.

• Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

• Unable to take colchicine for gout flare prophylaxis.

• History or suspicion of kidney stones.

• Any gastrointestinal disorder that affects motility and/or absorption.

• Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants.

• Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.

• Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.

• Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing.

• Unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.