Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

• Status: Completed
• Trial end date: 2016-06-02
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

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

Criteria

Inclusion Criteria:

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

• Subject 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.

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

• Subject has a Screening serum urate level ≥ 8 mg/dL.

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

Exclusion Criteria:

• Subject is unable to take colchicine for gout flare prophylaxis.

• Subject has a history or suspicion of kidney stones.

• Subject has any gastrointestinal disorder that affects motility and/or absorption.

• Subject had 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.

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

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

• Subject is 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.

• Subject is 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.