Open AccessRandomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Tebipenem Pivoxil Hydrobromide on QT/QTc Intervals in Healthy Subjects
Author(s) -
Vipul K Gupta,
Gary Maier,
Paul B Eckburg,
L Morelli,
Lei Yang,
Akash Jain,
Erika Manyak,
David Melnick
Publication year - 2021
Publication title -
antimicrobial agents and chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.07
H-Index - 259
eISSN - 1070-6283
pISSN - 0066-4804
DOI - 10.1128/aac.00145-21
Subject(s) - qt interval , moxifloxacin , medicine , crossover study , placebo , heart rate , cmax , anesthesia , pharmacology , pharmacokinetics , chemistry , blood pressure , antibiotics , biochemistry , alternative medicine , pathology
Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an orally available prodrug of tebipenem (TBP), a carbapenem within vitro activity against multidrug-resistant Gram-negative pathogens. This study evaluated the effects of single therapeutic and supratherapeutic doses of TBP-PI-HBr on the heart rate-corrected QT interval (QTc) by assessing the concentration-QT interval relationship using exposure-response modeling.