Expired Study
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Austin, Texas 78744


Purpose:

This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg tablets.


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 ≤ 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 (> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1 - Subject has inadequate venous access or unsuitable veins for repeated venipuncture - Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission) - Subject cannot swallow multiple tablets - Subject is a heavy caffeine drinker - Subject is unwilling to comply with the dietary restrictions of the study - 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


NCT ID:

NCT02336594


Primary Contact:

Study Director
J. Hall, MD
Ardea Biosciences, Inc.


Backup Contact:

N/A


Location Contact:

Austin, Texas 78744
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 17, 2017

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