A Phase I, Single-Ascending-Dose Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DS-2969b, a Novel GyrB Inhibitor

• Published in: Journal of clinical pharmacology Vol. 58; no. 12; p. 1557
• Main Authors: Dennie, Justin, Vandell, Alexander G, Inoue, Satoshi, Gajee, Roohi, Pav, Joseph, Zhang, George, Zamora, Cynthia, Masuda, Nobuhisa, Uchiyama, Minoru, Yamada, Makiko, Senaldi, Giorgio
• Format: Journal Article
• Language: English
• Published: England 01.12.2018
• Subjects: Adolescent; Adult; Area Under Curve; Bacteria - drug effects; Dose-Response Relationship, Drug; Female; Gastrointestinal Microbiome - drug effects; Half-Life; Humans; Imidazoles - administration & dosage; Imidazoles - adverse effects; Imidazoles - blood; Imidazoles - pharmacokinetics; Male; Middle Aged; Molecular Structure; Piperidines - administration & dosage; Piperidines - adverse effects; Piperidines - blood; Piperidines - pharmacokinetics; Thiadiazoles - administration & dosage; Thiadiazoles - adverse effects; Thiadiazoles - blood; Thiadiazoles - pharmacokinetics; Topoisomerase II Inhibitors - administration & dosage; Topoisomerase II Inhibitors - adverse effects; Topoisomerase II Inhibitors - blood; Topoisomerase II Inhibitors - pharmacokinetics; Young Adult; DS-2969b; antibiotic; antimicrobial agents; Clostridium difficile infection; Clostridium difficile

DS-2969b is a novel GyrB inhibitor in development for the treatment of Clostridium difficile infection. The aim of this study was to assess the safety, tolerability, pharmacokinetics, and effects on normal gastrointestinal microbiota groups of single daily oral ascending doses of DS-2969b in healthy...