Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

Phase 1 Completed 40 enrolled Melinta Therapeutics, Inc.

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetic profile, safety, and tolerability of a single intravenous (IV) dose of delafloxacin in normal healthy subjects and subjects with mild, moderate, or severe hepatic impairment.

Timeline

Start: 2014-09
Primary completion: 2015-02
Completion: 2015-02

Publications

Hoover R, Marbury TC, Preston RA, Quintas M, Lawrence LE, Paulson SK, Luke DR, Cammarata SK. Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment. J Clin Pharmacol. 2017 Mar;57(3):328-335. doi: 10.1002/jcph.817. Epub 2016 Oct 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Delafloxacin	Small molecule	300 mg	Intravenous

Indications

No indication recorded.