RDEA3170 and Febuxostat 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 and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.
Key facts
- Study ID
- NCT02246673
- Run by
- Ardea Biosciences, Inc.
- People needed
- 64
- Starts
- 2014-10-01
- Expected to finish
- 2016-02-01
- Last updated by the study team
- 2017-07-27
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Anaheim, California, United States
- Study site — Glendale, California, United States
- Study site — South Miami, Florida, United States
- Study site — Overland Park, Kansas, United States
- Study site — Overland Park, Kansas, United States
- Study site — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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