Pharmacokinetic Evaluation of Tirofiban Using a Single High-Dose Bolus In Subjects With Varying Degrees of Renal Function
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate tirofiban concentration in the blood over a period
of 24 hours after tirofiban administration. Subjects with varying degrees of renal
insufficiency (i.e. kidney function) will be included in the study. Tirofiban is known to be
cleared from the blood by the kidneys and so people with kidney problems clear tirofiban to a
slower extent compared to people without kidney problems. By comparing the tirofiban
concentration profile between subjects with healthy kidney function versus with impaired
kidney function, a tirofiban dosing recommendation for subjects with impaired kidney function
can be made.
This is a non-randomized, single-center, open-label study. A single dose of tirofiban (25
µg/kg administered intravenously over a 3 min period) will be administered to subjects with
normal renal function (>90 mL/min CrCl), moderate (30-59 mL/min CrCl), and severe (<30 mL/min
CrCl) renal impairment with non-dialysis-dependent renal insufficiency