First Time in Man Study of Finafloxacin Hydrochloride

Phase 1

Completed

• Conditions: Helicobacter Infections; Urinary Tract Infection
• Interventions: Drug: Finafloxacin hydrochloride

• Registration Number: NCT00483158
• Lead Sponsor: MerLion Pharmaceuticals GmbH

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.

Study Timeline

• Study First Submitted: 2007-06-04
• Study First Submitted QC: 2007-06-04
• Study First Posted: 2007-06-06
• Study Start: 2007-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-25
• Last Update Posted: 2008-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Finafloxacin hydrochloride	Rising Multiple Dose
C	Finafloxacin hydrochloride	Open Label H. pylori cohort
A	Finafloxacin hydrochloride	Rising Single Dose

Primary Outcome Measures

Name	Time	Method
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.	7 days

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects	7 days
To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl	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	7 days

Trial Locations

Locations (1)

Swiss Pharma Contract Ltd; 🇨🇭 Basel, Switzerland