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-Reference-Cited by-同舟云学术

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

Published:2019-12 Issue:12 Volume:63 Page:
ISSN:0066-4804
Container-title:Antimicrobial Agents and Chemotherapy
language:en
Short-container-title:Antimicrob Agents Chemother

Author:

Iwanowski Piotr¹,Bhatia Ashima²,Gupta Mugdha²,Patel Anasuya²,Chavan Rajesh²,Yeole Ravindra²,Friedland David³

Affiliation:

1. Wockhardt Bio AG, Zug, Switzerland

2. Wockhardt Ltd., Mumbai, India

3. Wockhardt’s Morton Grove Pharmaceuticals Inc., Morton Grove, Illinois, USA

Abstract

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.

Funder

Wockhardt Bio AG

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

Link

https://journals.asm.org/doi/pdf/10.1128/AAC.01253-19

Reference15 articles.

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3. Kohlhoff S, Hammerschlag MR. 2016. In vitro activity of WCK 4873, a second generation ketolide, against Chlamydia pneumoniae. Abstr ASM Microbe 2016, June 16 to 20, Boston, MA, abstr Monday-012.

4. Dubois J, Dubois M, Martel JF. 2016. In vitro intracellular activity of a novel lactone ketolide WCK 4873 against Legionella pneumophila. Abstr ASM Microbe 2016, June 16 to 20, Boston, MA, abstr Sunday-479.

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