RDEA3170 and Febuxostat Combination Study in Gout Subjects
Status: | Active, not recruiting |
---|---|
Conditions: | Gout |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 4/21/2016 |
Start Date: | October 2014 |
End Date: | December 2015 |
A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout
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.
(PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to
febuxostat administered alone in adult subjects with gout.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
6
sites
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