First Time in Man Study of Finafloxacin Hydrochloride

Study Overview
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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.

Official Title
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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

Conditions
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Helicobacter Infections, Urinary Tract Infection

Intervention / Treatment
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* Drug: Finafloxacin hydrochloride


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Rising Single Dose | Drug: Finafloxacin hydrochloride<br>* Tablets, oral single dose and multiple dose once daily for 7d<br>|
| Placebo Comparator: B<br>Rising Multiple Dose | Drug: Finafloxacin hydrochloride<br>* Tablets, oral single dose and multiple dose once daily for 7d<br>|
| Experimental: C<br>Open Label H. pylori cohort | Drug: Finafloxacin hydrochloride<br>* Tablets, oral single dose and multiple dose once daily for 7d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Fluoroquinolones, First in Man