Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483158
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
2007-06-04
Brief Title:
First Time in Man Study of Finafloxacin Hydrochloride
Sponsor:
MerLion Pharmaceuticals GmbH
Organization:
MerLion Pharmaceuticals GmbH
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Dose-Escalating Study of Single and Multiple Oral Doses of Finafloxacin Hydrochloride in Healthy Subjects and a Study of H Pylori Treatment in Healthy Carriers
Status:
COMPLETED
Status Verified Date:
2008-07
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:
The purpose of this study is to study the safety of single doses and multiple doses of Finafloxacin hydrochloride in healthy volunteers The level of Finafloxacin hydrochloride will be measured in the subjects blood and urine One part of the study will assess if Finafloxacin hydrochloride eradicates Helicobacter pylori a stomach bacteria Another part of the study will assess the activity of the drug in urine
Detailed Description:
New antibiotics are needed due to the increasing resistance of bacteria to existing antibiotics Helicobacter pylori H pylori is a bacteria of the stomach and has been shown to cause peptic ulcers and is implicated in gastric cancer Up to 40 of the population has H pylori Current treatments used to eradicate H pylori are a combination of a number of drugs including antibiotics and drugs which reduce the acid in the stomach These treatments are complicated and some H pylori is resistant to the antibiotics used
This study is the first use of Finafloxacin hydrochloride in man and will examine its safety and make a preliminary study of its effectiveness as a single agent in eradicating H pylori The urine of subjects will also be used to test its effectiveness in killing the bacteria which cause urinary tract infections
This study is the first use of Finafloxacin hydrochloride in man and will examine its safety and make a preliminary study of its effectiveness as a single agent in eradicating H pylori The urine of subjects will also be used to test its effectiveness in killing the bacteria which cause urinary tract infections
Study Oversight
Has Oversight DMC:
None
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?:
None