Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Tebipenem Pivoxil Hydrobromide on QT/QTc Intervals in Healthy Subjects-Reference-Cited by-同舟云学术

Randomized, Double-Blind, Placebo- and Positive-Controlled Crossover Study of the Effects of Tebipenem Pivoxil Hydrobromide on QT/QTc Intervals in Healthy Subjects

Published:2021-06-17 Issue:7 Volume:65 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Gupta Vipul K.¹^ORCID,Maier Gary²,Eckburg Paul¹^ORCID,Morelli Lisa¹,Lei Yang¹,Jain Akash¹,Manyak Erika³,Melnick David¹

Affiliation:

1. Spero Therapeutics, Inc., Cambridge, Massachusetts, USA

2. Maier Metrics and Associates, LLC, Falmouth, Maine, USA

3. Ribon Therapeutics, Inc., Cambridge, Massachusetts, USA

Abstract

Tebipenem pivoxil hydrobromide (TBP-PI-HBr) is an orally available prodrug of tebipenem (TBP), a carbapenem with in 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.

Funder

Spero Therapeutics

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.00145-21

Reference21 articles.

1. Long-QT Syndrome

2. Antibiotic-induced Cardiac Arrhythmias

3. Antimicrobial-Associated QT Interval Prolongation: Pointes of Interest

4. Antimicrobials and the Risk of Torsades de Pointes

5. Torsades de pointes and QT prolongation Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System

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1. Population Pharmacokinetic Analyses for Tebipenem after Oral Administration of Pro-Drug Tebipenem Pivoxil Hydrobromide;Antimicrobial Agents and Chemotherapy;2023-06-15

2. Effect of an Antacid (Aluminum Hydroxide/Magnesium Hydroxide/Simethicone) or a Proton Pump Inhibitor (Omeprazole) on the Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) in Healthy Adult Subjects;Antimicrobial Agents and Chemotherapy;2023-04-18

3. Plasma and Intrapulmonary Concentrations of Tebipenem following Oral Administration of Tebipenem Pivoxil Hydrobromide to Healthy Adult Subjects;Antimicrobial Agents and Chemotherapy;2022-07-19

4. Bioequivalence of two oral formulations of tebipenem pivoxil hydrobromide in healthy subjects;Clinical and Translational Science;2022-04-28