First Time in Man Study of Finafloxacin Hydrochloride

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection; Helicobacter Infections
• Intervention / Treatment: Drug: Finafloxacin hydrochloride

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4123
    • Swiss Pharma Contract Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: MerLion Pharmaceuticals GmbH
• Investigators: Principal Investigator: Michael Seiberling, MD, Swiss Pharma Contract Ltd

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: June 4, 2007
• First Submitted That Met QC Criteria: June 4, 2007
• First Posted (Estimate): June 6, 2007

Study Record Updates

• Last Update Posted (Estimate): July 29, 2008
• Last Update Submitted That Met QC Criteria: July 25, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Helicobacter pylori; First in Man; Fluoroquinolones
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Urinary Tract Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Renal Agents; Finafloxacin
• Other Study ID Numbers: FINA-001