A Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Study Overview
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Brief Summary
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The purpose of this study is to determine whether RDEA806 is effective in the treatment of hyperuricemia in gout patients.

Official Title
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Randomized, Double-Blind, Multicenter,Placebo-Controlled, Dose Ranging, Efficacy and Safety Study of RDEA806 in Hyperuricemic Subjects With Symptomatic Gout

Conditions
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Hyperuricemia

Intervention / Treatment
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* Drug: RDEA806
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL. Patient meets one or more of the 1977 ARA criteria for the diagnosis of gout. Patient is willing and able to give informed consent and adhere to visit/protocol schedules All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap). Exclusion Criteria: Consumes more than 14 drinks of alcohol per week. History or suspicion of drug abuse. History of kidney stones, rheumatoid arthritis or other autoimmune disease, significant cardiac dysfunction. Diabetes Mellitus requiring treatment Confirmed or suspected HIV-1 infection. Malignancy, except treated non-melanomatous skin cancer and cervical dysplasia. Uncontrolled hypertension. Inadequate renal function. Hemoglobin < 8 g/dL (males) or < 7 g/dL (females). ALT, AST , or GGT 2 x ULN Active peptic ulcer disease. Requires long-term use of salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim. Pregnant or breast feeding. Use of an investigational drug within 4 weeks prior to study drug administration. Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations. Any other medical or psychological condition which, in the opinion of the investigator, 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. History of cardiac abnormalities including abnormal and clinically relevant ECG changes. Conditions predisposing to QT prolongation. Any use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day 1. Subjects with a QTcF interval >450 milliseconds at screening or on Day -1 or at pre-dose (Hour 0) on Day 1.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>RDEA806 400 mg qd | Drug: RDEA806<br>* Uricosuric agent for the treatment of gout<br>|
| Experimental: 3<br>RDEA806 400 mg bid | Drug: RDEA806<br>* Uricosuric agent for the treatment of gout<br>|
| Placebo Comparator: 2<br>Placebo QD | Drug: Placebo<br>* Matching Placebo.<br>|
| Placebo Comparator: 4<br>Placebo BID | Drug: Placebo<br>* Matching Placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit. |  | 4 weeks | 
| To evaluate the absolute and percent reduction from baseline in sUA levels |  | 4 weeks | 
| To evaluate percent change in 24-hour urine uric acid level |  | 4 weeks |