Effect of age and sex on the pharmacokinetics and safety of avibactam in healthy volunteers

Clinical Therapeutics
Antoine Tarral, Henri Merdjan

Abstract

Avibactam is a novel non-β-lactam β-lactamase inhibitor currently being assessed in combination with ceftazidime, ceftaroline fosamil, and aztreonam. The objectives of this study were to investigate the pharmacokinetics, safety, and tolerability of avibactam in healthy young (aged 18-45 years) and elderly (aged ≥65 years) volunteers of both sexes. This was a Phase I, open-label study in which healthy volunteers aged ≥18 years were enrolled into 4 cohorts: young male, young female, elderly male, and elderly female (n = 8 in each group). Subjects were excluded if they had any condition requiring regular medication or any other relevant conditions. All subjects received a single dose of avibactam 500 mg/100 mL given intravenously over 30 minutes. Pharmacokinetic measurements included Cmax, Tmax, AUC0-∞, plasma clearance, and t½. Within the two age categories the mean age across male and female subjects was well matched. The majority of subjects in the young cohort were black (≥62.5%), whilst the majority of those in the elderly cohorts were white (≥75%). Mean avibactam plasma clearance was similar between the young male, young female, and elderly male cohorts (10.16, 10.34, and 9.82 L/h, respectively), and slightly lower in elderl...Continue Reading

References

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Citations

Jun 17, 2015·Journal of Infection and Chemotherapy : Official Journal of the Japan Society of Chemotherapy·Nobumitsu TominagaShampa Das
Apr 22, 2016·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·David van Duin, Robert A Bonomo
Nov 1, 2016·Expert Opinion on Pharmacotherapy·Sara A BuckmanJohn E Mazuski
Nov 8, 2017·Infection·Felipe Francisco TuonMarcelo R Formigoni-Pinto
Sep 30, 2017·The Journal of Antimicrobial Chemotherapy·David M LivermoreNeil Woodford
Jul 1, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Karen ChengAngela Wardman

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