First Time in Man Study of Finafloxacin Hydrochloride

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MerLion Pharmaceuticals GmbH
• Treatments: Finafloxacin; Fluoroquinolones

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.