Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2014-04-30
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Sequence B
Day 1: Lesinurad 400 mg (manufactured at Site 2); Day 5: Lesinurad 400 mg (manufactured at Site 1)
Lesinurad 400 mg (manufactured at Site 1)
Lesinurad 400 mg (manufactured at Site 2)
Sequence A
Day 1: Lesinurad 400 mg (manufactured at Site 1); Day 5: Lesinurad 400 mg (manufactured at Site 2)
Lesinurad 400 mg (manufactured at Site 1)
Lesinurad 400 mg (manufactured at Site 2)
Interventions
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Lesinurad 400 mg (manufactured at Site 1)
Lesinurad 400 mg (manufactured at Site 2)
Eligibility Criteria
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Inclusion Criteria
* 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 has 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 the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
18 Years
65 Years
MALE
Yes
Sponsors
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Ardea Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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J. Hall
Role: STUDY_DIRECTOR
Ardea Biosciences, Inc.
Locations
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Austin, Texas, United States
Countries
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Other Identifiers
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RDEA594-132
Identifier Type: -
Identifier Source: org_study_id
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