Clinical trial NCT00483158: First Time in Man Study of Finafloxacin Hydrochloride
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Helicobacter Infections
Urinary Tract Infection
Keywords: Helicobacter pylori
Fluoroquinolones
First in Man
Lead sponsor: MerLion Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2007-06-06
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 7 days
Secondary outcomes:
measure: To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects
timeFrame: 7 days
measure: To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl
timeFrame: 7 days
measure: 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
timeFrame: 7 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Swiss Pharma Contract Ltd
Study officials:
affiliation: SWISS PHARMA CONTRACT LTD
name: Michael Seiberling, MD
role: PRINCIPAL_INVESTIGATOR
References: