NCT01907867

Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin

An Open-Label Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin After Single and Multiple Doses Administered Orally in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: MerLion Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2013-07-25
• Last updated: 2017-02-20

Locations

1 site across 1 country: United States