Helicobacter Infections, Urinary Tract Infection
Conditions
Keywords
Helicobacter pylori, Fluoroquinolones, First in Man
Brief 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.
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.
Interventions
DRUGFinafloxacin hydrochloride
Tablets, oral single dose and multiple dose once daily for 7d
Sponsors
MerLion Pharmaceuticals GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| 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 |
Countries
Switzerland
Outcome results
None listed