Safety, Tolerability, and Pharmacokinetics of Oral Nafithromycin (WCK 4873) after Single or Multiple Doses and Effects of Food on Single-Dose Bioavailability in Healthy Adult Subjects
Author(s) -
Piotr Iwanowski,
Ashima Bhatia,
Mugdha Gupta,
Anasuya Patel,
Rajesh Chavan,
Ravindra Yeole,
David Friedland
Publication year - 2019
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.01253-19
Subject(s) - bioavailability , pharmacokinetics , tolerability , placebo , pharmacology , medicine , oral administration , adverse effect , alternative medicine , pathology
Nafithromycin (WCK 4873), a novel lactone-ketolide, was administered to healthy adult subjects in 2 randomized, double-blind, placebo-controlled, phase 1 studies. In the first-in-human study, single ascending oral doses of nafithromycin (100 to 1,200 mg) were administered to subjects under fasted or fed conditions, with effects of food on bioavailability of nafithromycin studied at the dose levels of 400 and 800 mg.
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