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

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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.


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
1962
mi
from 43215
Anaheim, CA
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910
mi
from 43215
Dallas, TX
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1968
mi
from 43215
Glendale, CA
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624
mi
from 43215
Overland Park, KS
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624
mi
from 43215
Overland Park, KS
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997
mi
from 43215
South Miami, FL
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