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NCT Number: NCT00483158

First Time in Man Study of Finafloxacin Hydrochloride

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.

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Key information

Conditions

Helicobacter Infections Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Infections Male Urogenital Diseases Urinary Tract Infection Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Swiss Pharma Contract Ltd

Basel, CH-4123, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Finafloxacin hydrochloride

Drug

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

Primary outcomes

  1. 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.

    Time frame: 7 days

Secondary outcomes

  1. To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects

    Time frame: 7 days

  2. To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl

    Time frame: 7 days

  3. 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

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

MerLion Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 6, 2007
Registry last updated
Jul 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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