Overview

Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

Status:
Completed
Trial end date:
2016-06-02
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ardea Biosciences, Inc.
Treatments:
Allopurinol
Verinurad
Criteria
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.