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Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin

NCT01907867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-02-20

No results posted yet for this study

Summary

This study investigates the safety, tolerability, and PK profile of finafloxacin as a novel fluoroquinolone and a potential therapeutic agent for lower respiratory infections such as bacterial pneumonia. A comparison of the PK profile of finafloxacin in plasma and lung ELF using different bronchoscopic ELF sampling techniques (BMS and BAL) is conducted.

Conditions

  • Safety and Tolerability

Interventions

DRUG

Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days

Sponsors & Collaborators

  • MerLion Pharmaceuticals GmbH

    lead INDUSTRY

Principal Investigators

  • Mark H. Gottfried, MD · Pulmonary Associates, PA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

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 NCT01907867 on ClinicalTrials.gov