Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

Launched by ARDEA BIOSCIENCES, INC. · Jul 13, 2015

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Eligibility 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.