RDEA3170 Monotherapy in Subjects With Gout

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ardea Biosciences, Inc.
• Treatments: Verinurad

Criteria

Inclusion Criteria:

• Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.

• Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.

• Subject has a body mass index < 40 kg/m2.

Exclusion Criteria:

• Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

• Subject has a history or suspicion of kidney stones.

• Subject has a history or suspicion of drug abuse within the past 5 years.

• Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.

• Subject has a known or suspected human immunodeficiency virus infection.

• Subject has a positive test for active hepatitis B or hepatitis C infection.

• Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.

• Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.

• Subject has a QT interval corrected for heart rate according to Fridericia's formula > 450 msec during the Screening Period, confirmed by a repeat assessment.

• Subject has uncontrolled hypertension.

• Subject has an estimated creatinine clearance < 60 mL/min.

• Subject has an alkaline phosphatase > 2.0 x upper limit of normal during the Screening Period.

• Subject has active liver disease or impaired hepatic function.

• Subject is receiving chronic treatment with more than 325 mg salicylates per day.

• Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.

• Subject is unable to take colchicine for gout flare prophylaxis.

• Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.

• Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.

• Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.

• Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.