NCT02245243

Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Melinta Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Delafloxacin	Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-09-19
• Last updated: 2015-04-30

Locations

2 sites across 1 country: United States