Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Study Overview
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Brief Summary
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This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

Official Title
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A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia

Conditions
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Gout and Hyperuricemia

Intervention / Treatment
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* Drug: RDEA3170
* Drug: Allopurinol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject meets any of the following criteria and with sUA ≤10.0 mg/dL: sUA level of >7.0 mg/dL at 7 days prior to baseline with gout; sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome); sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications. Exclusion Criteria: Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit. Subject has a history or suspicion of kidney stones. Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula Subject is receiving strong or moderate CYP3A inhibitors

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 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: RDEA3170 1<br>RDEA3170 5mg followed by RDEA3170 7.5mg | Drug: RDEA3170<br>* Oral Treatment<br>|
| Experimental: RDEA3170 2<br>RDEA3170 10mg followed by RDEA3170 12.5mg | Drug: RDEA3170<br>* Oral Treatment<br>|
| Experimental: RDEA3170 3<br>RDEA3170 12.5mg followed by RDEA3170 15mg | Drug: RDEA3170<br>* Oral Treatment<br>|
| Placebo Comparator: RDEA3170 4<br>RDEA3170 Placebo | Drug: Placebo<br>* Oral Treatment<br>|
| Other: Allopurinol<br>Allopurinol 200mg | Drug: Allopurinol<br>* Oral Treatment<br>* Other names: Allopurinol 200mg Sawai;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Changes of Serum Uric Acid Levels From Baseline Levels | The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group. | Baseline and Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL | To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit | Weeks 1,2,4,6,8,10,12,16,18,20,24 | 
| Percent Change in sUA | To compare percent change in sUA at each study visit. | Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24 | 
| Absolute Change of Serum Uric Acid Levels From Baseline Levels | To compare the absolute change of serum uric acid levels from baseline levels | Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24 |