South Miami, Florida 33143

  • Gout

Purpose:

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.


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.


NCT ID:

NCT02498652


Primary Contact:

Study Director
Jesse Hall, MD
Ardea Biosciences, Inc.


Backup Contact:

N/A


Location Contact:

South Miami, Florida 33143
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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