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First Time in Man Study of Finafloxacin Hydrochloride

NCT ID: NCT00483158

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-05-31

Brief Summary

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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

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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.

Conditions

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Helicobacter Infections Urinary Tract Infection

Keywords

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Helicobacter pylori Fluoroquinolones First in Man

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Rising Single Dose

Group Type PLACEBO_COMPARATOR

Finafloxacin hydrochloride

Intervention Type DRUG

Tablets, oral single dose and multiple dose once daily for 7d

B

Rising Multiple Dose

Group Type PLACEBO_COMPARATOR

Finafloxacin hydrochloride

Intervention Type DRUG

Tablets, oral single dose and multiple dose once daily for 7d

C

Open Label H. pylori cohort

Group Type EXPERIMENTAL

Finafloxacin hydrochloride

Intervention Type DRUG

Tablets, oral single dose and multiple dose once daily for 7d

Interventions

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Finafloxacin hydrochloride

Tablets, oral single dose and multiple dose once daily for 7d

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MerLion Pharmaceuticals GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Swiss Pharma Contract, Basel, Switzerland

Principal Investigators

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Michael Seiberling, MD

Role: PRINCIPAL_INVESTIGATOR

SWISS PHARMA CONTRACT LTD

Locations

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Swiss Pharma Contract Ltd

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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FINA-001

Identifier Type: -

Identifier Source: org_study_id