RDEA3170 and Allopurinol Combination Study in Gout Subjects
Completed · Phase 1
Conditions studied: Gout
In brief
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.
Key facts
- Study ID
- NCT02279641
- Run by
- Ardea Biosciences, Inc.
- People needed
- 12
- Starts
- 2014-11-01
- Expected to finish
- 2015-09-11
- Last updated by the study team
- 2017-12-20
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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 and ≤ 10 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 an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
- Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
- Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is 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 — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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