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Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects

The primary objective of the study was to evaluate the safety and tolerability of single oral doses of sutezolid tablets administered under fasting conditions in healthy adult subjects. The secondary objective was to determine the pharmacokinetics (PK) of sutezolid and two metabolites, PNU-101603 an...

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Autores principales: Bruinenberg, Paul, Nedelman, Jerry, Yang, Tian J., Pappas, Fran, Everitt, Dan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Microbiology 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9017382/
https://www.ncbi.nlm.nih.gov/pubmed/35285241
http://dx.doi.org/10.1128/aac.02108-21
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author Bruinenberg, Paul
Nedelman, Jerry
Yang, Tian J.
Pappas, Fran
Everitt, Dan
author_facet Bruinenberg, Paul
Nedelman, Jerry
Yang, Tian J.
Pappas, Fran
Everitt, Dan
author_sort Bruinenberg, Paul
collection PubMed
description The primary objective of the study was to evaluate the safety and tolerability of single oral doses of sutezolid tablets administered under fasting conditions in healthy adult subjects. The secondary objective was to determine the pharmacokinetics (PK) of sutezolid and two metabolites, PNU-101603 and PNU-101244. Overall, sutezolid was well tolerated when administered as a 300-mg, 600-mg, 1,200-mg, or 1,800-mg dose in healthy adult subjects under fasting conditions. Maximum concentration (C(max)) of sutezolid, PNU-101603, and PNU-101244 increased in a less-than-proportional manner with an increase in sutezolid dose between 300 mg and 1,800 mg. Total exposure (AUC(last) [area under the concentration-time curve from time zero to the time of the last quantifiable concentration] and AUC(inf) [area under the plasma concentration time curve from time zero extrapolated to infinity]) of sutezolid, PNU-101603, and PNU-101244 increased proportionally with an increase in sutezolid dose.
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spelling pubmed-90173822022-04-20 Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects Bruinenberg, Paul Nedelman, Jerry Yang, Tian J. Pappas, Fran Everitt, Dan Antimicrob Agents Chemother Clinical Therapeutics The primary objective of the study was to evaluate the safety and tolerability of single oral doses of sutezolid tablets administered under fasting conditions in healthy adult subjects. The secondary objective was to determine the pharmacokinetics (PK) of sutezolid and two metabolites, PNU-101603 and PNU-101244. Overall, sutezolid was well tolerated when administered as a 300-mg, 600-mg, 1,200-mg, or 1,800-mg dose in healthy adult subjects under fasting conditions. Maximum concentration (C(max)) of sutezolid, PNU-101603, and PNU-101244 increased in a less-than-proportional manner with an increase in sutezolid dose between 300 mg and 1,800 mg. Total exposure (AUC(last) [area under the concentration-time curve from time zero to the time of the last quantifiable concentration] and AUC(inf) [area under the plasma concentration time curve from time zero extrapolated to infinity]) of sutezolid, PNU-101603, and PNU-101244 increased proportionally with an increase in sutezolid dose. American Society for Microbiology 2022-03-14 /pmc/articles/PMC9017382/ /pubmed/35285241 http://dx.doi.org/10.1128/aac.02108-21 Text en Copyright © 2022 Bruinenberg 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
Bruinenberg, Paul
Nedelman, Jerry
Yang, Tian J.
Pappas, Fran
Everitt, Dan
Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title_full Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title_fullStr Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title_full_unstemmed Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title_short Single Ascending-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid in Healthy Adult Subjects
title_sort single ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of sutezolid in healthy adult subjects
topic Clinical Therapeutics
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9017382/
https://www.ncbi.nlm.nih.gov/pubmed/35285241
http://dx.doi.org/10.1128/aac.02108-21
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