A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function

Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. 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 7.5-mg/kg of body weight dose of plazomicin as a 30...

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Autores principales: Komirenko, Allison S., Riddle, Valerie, Gibbons, Jacqueline A., Van Wart, Scott, Seroogy, Julie D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Microbiology 2018
Materias:
Clinical Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6256775/
https://www.ncbi.nlm.nih.gov/pubmed/30275092
http://dx.doi.org/10.1128/AAC.01128-18
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author Komirenko, Allison S.
Riddle, Valerie
Gibbons, Jacqueline A.
Van Wart, Scott
Seroogy, Julie D.
author_facet Komirenko, Allison S.
Riddle, Valerie
Gibbons, Jacqueline A.
Van Wart, Scott
Seroogy, Julie D.
author_sort Komirenko, Allison S.
collection PubMed
description Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. 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 7.5-mg/kg of body weight dose of plazomicin as a 30-min intravenous infusion. Total clearance declined with renal impairment, resulting in 1.98-fold and 4.42-fold higher plazomicin exposures, as measured by the area under the concentration-time curve from 0 h to infinity, in subjects with moderate and severe impairment, respectively, than in subjects with normal renal function. (This study has been registered at ClinicalTrials.gov under identifier NCT01462136.)
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spelling pubmed-62567752018-12-10 A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function Komirenko, Allison S. Riddle, Valerie Gibbons, Jacqueline A. Van Wart, Scott Seroogy, Julie D. Antimicrob Agents Chemother Clinical Therapeutics Plazomicin is an FDA-approved aminoglycoside for the treatment of complicated urinary tract infections. 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 7.5-mg/kg of body weight dose of plazomicin as a 30-min intravenous infusion. Total clearance declined with renal impairment, resulting in 1.98-fold and 4.42-fold higher plazomicin exposures, as measured by the area under the concentration-time curve from 0 h to infinity, in subjects with moderate and severe impairment, respectively, than in subjects with normal renal function. (This study has been registered at ClinicalTrials.gov under identifier NCT01462136.) American Society for Microbiology 2018-11-26 /pmc/articles/PMC6256775/ /pubmed/30275092 http://dx.doi.org/10.1128/AAC.01128-18 Text en Copyright © 2018 Komirenko et al. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Clinical Therapeutics
Komirenko, Allison S.
Riddle, Valerie
Gibbons, Jacqueline A.
Van Wart, Scott
Seroogy, Julie D.
A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title_full A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title_fullStr A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title_full_unstemmed A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title_short A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function
title_sort phase 1 study to assess the pharmacokinetics of intravenous plazomicin in adult subjects with varying degrees of renal function
topic Clinical Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6256775/
https://www.ncbi.nlm.nih.gov/pubmed/30275092
http://dx.doi.org/10.1128/AAC.01128-18
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