A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Oral tablets, single dose
Research Site
Orlando, Florida, United States
Plasma pharmacokinetic (PK) parameters
Parameters include: AUC, Cmax
Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms
Urine PK parameters of R406 and its N-glucuronide metabolite
PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)
The effects of differences in protein binding by assessment of unbound R406 PK
PK parameters including, but not limited to, unbound AUC and unbound Cmaxt
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