Murepavadin, a novel antipseudomonal antibiotic: Pharmacokinetics, tolerability and safety in subjects with mild, moderate, and severe renal function impairment.

Murepavadin, a novel antipseudomonal antibiotic: Pharmacokinetics, tolerability and safety in subjects with mild, moderate, and severe renal function impairment. Antimicrob Agents Chemother. 2018 Jul 16;: Authors: Dale GE, Halabi A, Petersen-Sylla M, Wach A, Zwingelstein C Abstract This open-label, non-randomized, single-dose, Phase I study evaluated the pharmacokinetics and safety of murepavadin, a novel peptide antibiotic for the treatment of serious Pseudomonas aeruginosa infections. The study was conducted in 32 subjects of either sex in 4 groups (in up to 8 per group) with mild (group A), moderate (group B), severe (group C) renal function impairment or with normal renal function (group D). The degree of renal impairment of the subjects was classified at screening according to the estimated creatinine clearance (CLCr) according to the Cockcroft-Gault equation. All subjects received a single 2.2 mg/kg intravenous infusion of murepavadin administered over 3 hours. Exposure to murepavadin in plasma increased in subjects with renal function impairment with AUC0-∞ increasing about 2.0- to 2.5-fold for subjects with renal function impairment compared to subjects with normal renal function, whereas, the increases in Cmax were about 1.5-fold for subjects with renal function impairment compared to subjects with normal renal function. Total clearance (CL) of murepavadin was lower in all groups of subjects with renal function impairment,...
Source: Antimicrobial Agents and Chemotherapy - Category: Microbiology Authors: Tags: Antimicrob Agents Chemother Source Type: research