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Sponsored by: |
MerLion Pharmaceuticals GmbH |
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Information provided by: | MerLion Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00483158 |
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 |
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Helicobacter Infections Urinary Tract Infection |
Drug: Finafloxacin hydrochloride |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
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 |
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 |
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A: Placebo Comparator
Rising Single Dose
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Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
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B: Placebo Comparator
Rising Multiple Dose
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Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
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C: Experimental
Open Label H. pylori cohort
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Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
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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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Swiss Pharma Contract, Basel, Switzerland ( Michael Seiberling, MD, Prinzipal Study Investigator ) |
Study ID Numbers: | FINA-001 |
Study First Received: | June 4, 2007 |
Last Updated: | July 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00483158 |
Health Authority: | Switzerland: Swissmedic |
Helicobacter pylori Fluoroquinolones First in Man |
Bacterial Infections Fluoroquinolones Urologic Diseases Urinary Tract Infections |
Healthy Helicobacter Infections Gram-Negative Bacterial Infections |
Communicable Diseases Infection |