Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-03-05 @ 8:51 AM
Study NCT ID:
NCT00483158
Status:
COMPLETED
Last Update Posted:
2008-07-29
First Post:
2007-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Time in Man Study of Finafloxacin Hydrochloride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016481', 'term': 'Helicobacter Infections'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-25', 'studyFirstSubmitDate': '2007-06-04', 'studyFirstSubmitQcDate': '2007-06-04', 'lastUpdatePostDateStruct': {'date': '2008-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'To determine the pharmacokinetic profile of single and multiple oral doses of Finafloxacin HCl in healthy subjects', 'timeFrame': '7 days'}, {'measure': 'To determine the bactericidal activity of urine obtained from healthy subjects after administration of Finafloxacin HCl', 'timeFrame': '7 days'}, {'measure': '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', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Fluoroquinolones', 'First in Man'], 'conditions': ['Helicobacter Infections', 'Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female healthy subjects\n* 18-55 years of age\n* In good health\n* For part C only, Helicobacter pylori carrier status as assessed by a positive result of the urease breath test at screening.\n\nExclusion Criteria:\n\n* Abnormal physical findings of clinical significance at the Screening examination or baseline which would interfere with the objectives of the study.'}, 'identificationModule': {'nctId': 'NCT00483158', 'briefTitle': 'First Time in Man Study of Finafloxacin Hydrochloride', 'organization': {'class': 'INDUSTRY', 'fullName': 'MerLion Pharmaceuticals GmbH'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FINA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'Rising Single Dose', 'interventionNames': ['Drug: Finafloxacin hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Rising Multiple Dose', 'interventionNames': ['Drug: Finafloxacin hydrochloride']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'Open Label H. pylori cohort', 'interventionNames': ['Drug: Finafloxacin hydrochloride']}], 'interventions': [{'name': 'Finafloxacin hydrochloride', 'type': 'DRUG', 'description': 'Tablets, oral single dose and multiple dose once daily for 7d', 'armGroupLabels': ['A', 'B', 'C']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4123', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Swiss Pharma Contract Ltd', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Michael Seiberling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SWISS PHARMA CONTRACT LTD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MerLion Pharmaceuticals GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Michael Seiberling, MD, Prinzipal Study Investigator', 'oldOrganization': 'Swiss Pharma Contract, Basel, Switzerland'}}}}