This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
48
University of Miami,Division of Clinical Pharmacology
Miami, Florida, United States
plasma concentrations (Cmax)
Time frame: 48 hrs
Tmax The elimination half-life (t1/2),
Time frame: 48 hrs
Number of Participants With Abnormal Laboratory Values
Time frame: 14 days
Number of Participants With Adverse Events
Time frame: 14 days
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