RDEA3170 Monotherapy in Subjects With Gout

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 172

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo group
RDEA3170 5 mg qd	RDEA3170 5 mg	No titration.
RDEA3170 10 mg qd	RDEA3170 10 mg	Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.
RDEA3170 12.5 mg qd	RDEA3170 12.5 mg	Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.

Primary Outcome Measures

Name	Time	Method
Efficacy of RDEA3170 monotherapy at Week 12	Week 12	Percent change from baseline in serum urate levels at Week 12.

Secondary Outcome Measures

Name	Time	Method
Efficacy of RDEA3170 monotherapy at Week 24	Week 24	Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level \< 6.0 and \< 5.0 mg/dL at each visit.
Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms	8 months	Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.