Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01287793
Status:
COMPLETED
Last Update Posted:
2011-05-24
First Post:
2011-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078304', 'term': 'Tigecycline'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-23', 'studyFirstSubmitDate': '2011-01-21', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in serial QTc measurements in healthy volunteers up to 96 hours after single tigecycline doses', 'timeFrame': 'Up to 96 hours'}], 'secondaryOutcomes': [{'measure': "QTc, using Fredericia's correction at each time point during moxifloxacin treatment periods", 'timeFrame': '-2.5, -2, -1.5, -1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Maximum concentration pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Time of maximum concentration pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Elimination rate constant pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Half life pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Area under the concentration time curve to last measured concentrations pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Area under the concentration time curve extrapolated to infinity pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Clearance pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Volume of distribution at steady-state pharmacokinetic endpoint for tigecycline', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}, {'measure': 'Response-exposure relationships between QT/QTc and tigecycline concentration', 'timeFrame': '-1, 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48, 72, 96 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23403419', 'type': 'DERIVED', 'citation': 'Korth-Bradley JM, McGovern PC, Salageanu J, Matschke K, Plotka A, Pawlak S. Tigecycline does not prolong corrected QT intervals in healthy subjects. Antimicrob Agents Chemother. 2013 Apr;57(4):1895-901. doi: 10.1128/AAC.01576-12. Epub 2013 Feb 12.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1811062&StudyName=Study%20To%20Evaluate%20The%20Effect%20Of%20Single%20Intravenous%20Doses%20Of%20Tigecycline%20On%20QTc%20Intervals%20In%20Healthy%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Administration of a single 50 mg or 200 mg dose of tigecycline will not cause a change in QT/QTc intervals.', 'detailedDescription': 'evaluation of effect of tigecycline on QT/QTc in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Body mass index 17.5 - 30.5 kg\n* Total body weight greater than 50 kg\n\nExclusion Criteria:\n\n* Recent history of diarrhea\n* Use of oral antibiotics in the last 2 weeks\n* History of risk factors for QT prolongation pregnant females\n* Nursing females'}, 'identificationModule': {'nctId': 'NCT01287793', 'briefTitle': 'Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Randomized, 4-Way, Crossover Single Dose, Placebo And Active Controlled Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B1811062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'high dose tigecycline', 'interventionNames': ['Drug: tigecycline']}, {'type': 'EXPERIMENTAL', 'label': 'regular dose tigecycline', 'interventionNames': ['Drug: tigecycline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'moxifloxacin', 'interventionNames': ['Drug: moxifloxacin', 'Drug: 100 mL 0.9% Sodium Chloride intravenous']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'tigecycline', 'type': 'DRUG', 'otherNames': ['Tygacil, GAR-936'], 'description': 'intravenous, 200 mg, single dose', 'armGroupLabels': ['high dose tigecycline']}, {'name': 'tigecycline', 'type': 'DRUG', 'otherNames': ['Tygacil, GAR-936'], 'description': 'intravenous, 50 mg, single dose', 'armGroupLabels': ['regular dose tigecycline']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'description': 'oral tablet, 400 mg, single dose', 'armGroupLabels': ['moxifloxacin']}, {'name': '100 mL 0.9% Sodium Chloride intravenous', 'type': 'DRUG', 'description': 'intravenous fluid, 100 mL, single dose', 'armGroupLabels': ['moxifloxacin']}, {'name': 'placebo', 'type': 'DRUG', 'description': '0.9% Sodium Chloride intravenous 100mL, single dose', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}