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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00483158 |
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Date of registration:
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04/06/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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First Time in Man Study of Finafloxacin Hydrochloride
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Scientific title:
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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 |
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Date of first enrolment:
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August 2007 |
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Target sample size:
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95 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00483158 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Michael Seiberling, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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SWISS PHARMA CONTRACT LTD |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Helicobacter Infections
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Urinary Tract Infection
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Intervention(s)
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Drug: Finafloxacin hydrochloride
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl
[Time Frame: 7 days]
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To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects
[Time Frame: 7 days]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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