NCT00483158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

9 months

First QC Date

June 4, 2007

Last Update Submit

July 25, 2008

Conditions

Helicobacter InfectionsUrinary Tract Infection

Keywords

Helicobacter pyloriFluoroquinolonesFirst in Man

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

A

PLACEBO COMPARATOR

Rising Single Dose

Drug: Finafloxacin hydrochloride

B

PLACEBO COMPARATOR

Rising Multiple Dose

Drug: Finafloxacin hydrochloride

C

EXPERIMENTAL

Open Label H. pylori cohort

Drug: Finafloxacin hydrochloride

Interventions

Finafloxacin hydrochlorideDRUG

Tablets, oral single dose and multiple dose once daily for 7d

ABC

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female healthy subjects
  • 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.

You may not qualify if:

  • Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Pharma Contract Ltd

Basel, CH-4123, Switzerland

Location

MeSH Terms

Conditions

Helicobacter InfectionsUrinary Tract Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael Seiberling, MD

    SWISS PHARMA CONTRACT LTD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 4, 2007

First Posted

June 6, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

CH(1)