Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Completed · Phase 2
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT02498652
- Run by
- Ardea Biosciences, Inc.
- People needed
- 41
- Starts
- 2015-07-28
- Expected to finish
- 2016-06-02
- Last updated by the study team
- 2018-01-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Anaheim, California, United States
- Study site — DeLand, Florida, United States
- Study site — South Miami, Florida, United States
- Study site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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