Expired Study
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Austin, Texas 78744


Purpose:

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.


Study summary:

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.


Criteria:

Inclusion Criteria: - Body mass index ranging between 18 kg/m2 and 40 kg/m2. - Screening serum urate level is ≤ 7.0 mg/dL. Exclusion Criteria: - Asian subject who has a positive test for the HLA-B*5801 allele. - History or suspicion of kidney stones. - Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight. - Undergone major surgery within 3 months prior to Screening. - Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or has given a plasma donation within 4 weeks prior to Day 1. - Inadequate venous access or unsuitable veins for repeated venipuncture. - Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.


NCT ID:

NCT02581553


Primary Contact:

Study Director
N. Bhakta
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 18, 2019

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