RDEA3170 Tablet and Capsule Bioavailability Study
Condition: Healthy
Intervention: RDEA3170,10 mg; RDEA3170, 2.5 mg; RDEA3170, 5 mg; RDEA3170, 10 mg; RDEA3170, 2.5 mg
Intervention description: Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.; Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Intervention MeSH terms: Verinurad
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules
      compared with RDEA3170 tablets.
    

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 has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40
             kg/m2.

          -  Subject has a Screening serum urate level of 4 to 7 mg/dL.

          -  Subject is free of any clinically significant disease or medical condition, per the
             Investigator's judgment.

        Exclusion Criteria:

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has undergone major surgery within 3 months prior to Screening.

          -  Subject donated blood or experienced significant blood loss within 12 weeks prior to
             Day 1 or gave a plasma donation within 4 weeks prior to Day 1.

          -  Subject has clinically unacceptable physical examination, per the Investigator's
             judgment.

          -  Subject has clinically relevant abnormalities in blood pressure, heart rate, or body
             temperature, per the Investigator's judgment.

          -  Subject has Screening clinical safety laboratory parameters (serum chemistry [other
             than serum creatinine and serum urate], hematology, coagulation or urinalysis) that
             are outside the normal limits and are considered clinically significant by the
             Investigator.

          -  Subject has a serum creatinine value above the upper limit of normal at the Screening
             visit.

          -  Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the
             Investigator's judgment.

          -  Subject has a history of cardiac abnormalities

          -  Subject cannot swallow multiple tablets or capsules.

          -  Subject has received any strong or moderate enzyme-inducing drug or product within 2
             months prior to Day 1.