First Time in Man Study of Finafloxacin Hydrochloride

Urinary Tract Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00483158
• Other study ID #: FINA-001
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2007
• Last updated: July 25, 2008
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2008
• Source: MerLion Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d

Locations

Country	Name	City	State
Switzerland	Swiss Pharma Contract Ltd	Basel

Sponsors (1)

Lead Sponsor	Collaborator
MerLion Pharmaceuticals GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects		7 days
Secondary	To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl		7 days
Secondary	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