Abstract
To assess the safety and tolerability, and the effect of sex on the pharmacokinetic disposition, of a single intravenous dose of telavancin 10 mg/kg in elderly (> or = 65 yrs) subjects. Phase I, open-label, single-dose, sex-stratified study. Clinical research unit. Eight healthy men and eight healthy women (mean +/- SD ages 70.6 +/- 6.1 and 70.8 +/- 5.5 yrs, respectively). Each subject received a 60-minute intravenous infusion of telavancin 10 mg/kg. For the pharmacokinetic analysis, blood samples were collected before drug administration and at regular intervals up to 48 hours after the start of the infusion. Telavancin plasma concentrations were determined by liquid chromatography with tandem mass spectrometric detection. Pharmacokinetic parameters of telavancin were determined by noncompartmental analysis. Standard clinical laboratory tests and electrocardiograms were used to assess safety and tolerability. The telavancin plasma concentration-time curves and pharmacokinetic parameters for both sexes were comparable. Pooled mean +/- SD clearance, half-life, and volume of distribution at the steady state were 12.2 +/- 1.4 ml/hour/kg, 9.3 +/- 1.3 hours, and 156 +/- 12 ml/kg, respectively. The pooled mean +/- SD plasma concentra...Continue Reading
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