Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Status: | Completed |
---|---|
Conditions: | Gout |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 1/24/2018 |
Start Date: | July 28, 2015 |
End Date: | June 2, 2016 |
A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
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.
(PD) effects of RDEA3170 administered in combination with allopurinol compared with
allopurinol administered alone in adult subjects with gout.
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.
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