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First Time in Man Study of Finafloxacin Hydrochloride

This study has been completed.
Sponsor:
Information provided by:
MerLion Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00483158
First received: June 4, 2007
Last updated: July 25, 2008
Last verified: July 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Helicobacter Infections
Urinary Tract Infection
 Drug: Finafloxacin hydrochloride
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by MerLion Pharmaceuticals GmbH:

Primary Outcome 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 Outcome 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 ]

Enrollment: 95
Study Start Date: August 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
Rising Single Dose
 Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
Placebo Comparator: B
Rising Multiple Dose
 Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
Experimental: C
Open Label H. pylori cohort
 Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483158

Locations
Switzerland
Swiss Pharma Contract Ltd
Basel, Switzerland, CH-4123
Sponsors and Collaborators
MerLion Pharmaceuticals GmbH
Investigators
Principal Investigator: Michael Seiberling, MD SWISS PHARMA CONTRACT LTD
  More Information

No publications provided

Responsible Party: Michael Seiberling, MD, Prinzipal Study Investigator, Swiss Pharma Contract, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00483158     History of Changes
Other Study ID Numbers: FINA-001
Study First Received: June 4, 2007
Last Updated: July 25, 2008
Health Authority: Switzerland: Swissmedic

Keywords provided by MerLion Pharmaceuticals GmbH:
Helicobacter pylori
Fluoroquinolones
First in Man

Additional relevant MeSH terms:
Urinary Tract Infections
Helicobacter Infections
Infection
Urologic Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Fluoroquinolones
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013