First Time in Man Study of Finafloxacin Hydrochloride

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2008

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.

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: A
    • Rising Single Dose
  • Placebo Comparator: B
    • Rising Multiple Dose
  • Experimental: C
    • Open Label H. pylori cohort

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • MerLion Pharmaceuticals GmbH
  • Provider of Information About this Clinical Study
    • Michael Seiberling, MD, Prinzipal Study Investigator, Swiss Pharma Contract, Basel, Switzerland
  • Overall Official(s)
    • Michael Seiberling, MD, Principal Investigator, SWISS PHARMA CONTRACT LTD

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