First Time in Man Study of Finafloxacin Hydrochloride - Full Text View

Purpose

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.

Condition	Intervention	Phase
Helicobacter Infections Urinary Tract Infection	Drug: Finafloxacin hydrochloride	Phase I

MedlinePlus related topics:

Urinary Tract Infections

ChemIDplus related topics:

Finafloxacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

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

Further study details as provided by MerLion Pharmaceuticals GmbH:

Primary Outcome Measures:

To evaluate the safety and tolerability of single and multiple oral doses of Finafloxacin HCl by assessing adverse events, physical examinations, clinical chemistry examination, hematology, ECG and urinalysis. [ Time Frame: 7 days ]

Secondary Outcome Measures:

To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects [ Time Frame: 7 days ]
To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl [ Time Frame: 7 days ]
To explore the activity of multiple oral doses of Finafloxacin HCl against Helicobacter pylori using the effect on the urease breath test in healthy carriers as a model [ Time Frame: 7 days ]

Enrollment:	95
Study Start Date:	August 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator Rising Single Dose	Drug: Finafloxacin hydrochloride Tablets, oral single dose and multiple dose once daily for 7d
B: Placebo Comparator Rising Multiple Dose	Drug: Finafloxacin hydrochloride Tablets, oral single dose and multiple dose once daily for 7d
C: Experimental Open Label H. pylori cohort	Drug: Finafloxacin hydrochloride Tablets, oral single dose and multiple dose once daily for 7d

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female healthy subjects
18-55 years of age
In good health
For part C only, Helicobacter pylori carrier status as assessed by a positive result of the urease breath test at screening.

Exclusion Criteria:

Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483158

Locations


Switzerland
	Swiss Pharma Contract Ltd
	Basel, Switzerland, CH-4123

Sponsors and Collaborators

MerLion Pharmaceuticals GmbH

Investigators


Principal Investigator:	Michael Seiberling, MD	SWISS PHARMA CONTRACT LTD

More Information

Responsible Party:	Swiss Pharma Contract, Basel, Switzerland ( Michael Seiberling, MD, Prinzipal Study Investigator )
Study ID Numbers:	FINA-001
First Received:	June 4, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00483158
Health Authority:	Switzerland: Swissmedic