Mild, Moderate and Severe Renal Impairment Study
Status: | Active, not recruiting |
---|---|
Conditions: | Gout, Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology, Rheumatology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 4/21/2016 |
Start Date: | August 2014 |
End Date: | January 2016 |
A Phase 1, Single-Dose, Open Label, Pharmacokinetic and Pharmacodynamic Study of RDEA3170 in Adult Male Subjects With Mild, Moderate, and Severe Renal Impairment
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.
study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
Inclusion Criteria:
- 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 Criteria:
- 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
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