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

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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.


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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