First Time in Man Study of Finafloxacin Hydrochloride

MerLion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Urinary Tract Infection; Helicobacter Infections

Treatments: Drug: Finafloxacin hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00483158

FINA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

95 participants in 3 patient groups, including a placebo group

A

Placebo Comparator group

Description:

Rising Single Dose

Treatment:

Drug: Finafloxacin hydrochloride

B

Placebo Comparator group

Description:

Rising Multiple Dose

Treatment:

Drug: Finafloxacin hydrochloride

C

Experimental group

Description:

Open Label H. pylori cohort

Treatment:

Drug: Finafloxacin hydrochloride