Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-01-08 @ 4:18 PM
Study NCT ID:
NCT01907867
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2013-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin
Sponsor:
MerLion Pharmaceuticals GmbH
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: