Overview

RDEA3170 and Febuxostat Combination Study in Gout Subjects

Status:
Completed
Trial end date:
2016-02-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ardea Biosciences, Inc.
Treatments:
Febuxostat
Verinurad
Criteria
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.