Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
Condition: Gout
MeSH terms: Gout
Intervention: RDEA3170 2.5 mg; allopurinol 300 mg
Intervention description: Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets).
Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).; allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)
Intervention MeSH terms: Allopurinol; Verinurad
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic
      (PD) effects of RDEA3170 administered in combination with allopurinol compared with
      allopurinol administered alone in adult subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is able to understand the study procedures and the risks involved and is
             willing to provide written informed consent before the first study-related activity.

          -  Subject meets one or more criteria for the diagnosis of gout as per the American
             Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary
             Gout.

          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45
             kg/m2.

          -  Subject has a Screening serum urate level ≥ 8 mg/dL.

          -  Subject is free of any clinically significant disease or medical condition, per the
             Investigator's judgment.

        Exclusion Criteria:

          -  Subject is unable to take colchicine for gout flare prophylaxis.

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has any gastrointestinal disorder that affects motility and/or absorption.

          -  Subject had unstable angina, New York Heart Association class III or IV heart failure,
             ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to
             Day 1; or subject is currently receiving anticoagulants.

          -  Subject has Screening laboratory parameters that are outside the normal limits and are
             considered clinically significant by the Investigator.

          -  Subject has an estimated creatinine clearance < 60 mL/min calculated by the
             Cockcroft-Gault formula using ideal body weight during the Screening period.

          -  Subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked
             transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable
             for at least 14 days prior to study medication dosing.

          -  Subject is unable or unwilling to comply with the study requirements or has a
             situation or condition that, in the opinion of the Investigator, may interfere with
             participation in the study.