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Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

NCT02245243 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-04-30

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

Delafloxacin

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

Sponsors & Collaborators

  • Melinta Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sue K Cammarata, MD · CMO, MelintaTtherapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02245243 on ClinicalTrials.gov