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

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

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.

Inclusion Criteria:

• Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

  1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
  2. 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);
  3. 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