A Phase 1 Study to Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function [Clinical Therapeutics]

Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infection. In this open-label study, 24 adults with normal renal function or mild, moderate, or severe renal impairment (n = 6 per group) received a single dose of plazomicin 7.5 mg/kg as a 30-min intravenous infusion. Total clearance declined with renal impairment, resulting in 1.98-fold and 4.42-fold higher plazomicin AUC_0– values in subjects with moderate and severe impairment, respectively, relative to normal renal function.

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