A Phase 1 interventional study of Finafloxacin hydrochloride in Helicobacter Infections and Urinary Tract Infection, sponsored by MerLion Pharmaceuticals GmbH. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-29.
Sponsored by MerLion Pharmaceuticals GmbH · Phase 1, Interventional, and Treatment
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.
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 95 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →MerLion Pharmaceuticals GmbH is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Rising Single Dose
Drug: Finafloxacin hydrochloride
Rising Multiple Dose
Drug: Finafloxacin hydrochloride
Open Label H. pylori cohort
Drug: Finafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
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
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
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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MerLion Pharmaceuticals GmbH