Status:
COMPLETED
Mild, Moderate and Severe Renal Impairment Study
Lead Sponsor:
Ardea Biosciences, Inc.
Conditions:
Gout
Eligibility:
MALE
18-85 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
Eligibility Criteria
Inclusion
- Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
- Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to \< 90 mL/min (mild impairment), 30 to \< 60 mL/min (moderate impairment), or 15 to \< 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min.
- Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL
Exclusion
- Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subject has a history or suspicion of kidney stones.
- Subject has a history of asthma.
- Subject has undergone major surgery within 3 months prior to Day 1.
- Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2016
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT02219516
Start Date
August 1 2014
End Date
May 13 2016
Last Update
April 25 2017
Active Locations (4)
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1
Lakewood, Colorado, United States, 80228
2
Orlando, Florida, United States, 32809
3
Minneapolis, Minnesota, United States, 55404
4
Knoxville, Tennessee, United States, 37920