Primary Objective: To study the effect of mild, moderate and severe renal impairment on the pharmacokinetics of SAR302503. Secondary Objective: To assess the tolerability of SAR302503 given as a single 300 mg dose in subjects with mild, moderate and severe renal impairment and in matched subjects with normal renal function.
study duration = 17 to 35 days
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Pharmaceutical form:capsule Route of administration: oral
Investigational Site Number 840002
Orlando, Florida, United States
Investigational Site Number 840003
Saint Paul, Minnesota, United States
Investigational Site Number 840001
Knoxville, Tennessee, United States
Pharmacokinetic parameter: Cmax, AUClast and AUC
Time frame: 12 days
Pharmacokinetic parameters : unbound AUC, unbound Cmax, CL/F, Vss/F , t1/2z, t1/2eff, Rac, pred
Time frame: 12 days
Safety parameters including Clinical tests
Time frame: 16 days
Safety parameters including laboratory tests
Time frame: 16 days
Safety parameters including ECG parameters
Time frame: 16 days
Number of subjects with adverse events (AEs)
Time frame: 16 days
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