Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT00788294
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2008-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549319', 'term': 'tanezumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2008-11-07', 'studyFirstSubmitQcDate': '2008-11-07', 'lastUpdatePostDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subcutaneous bioavailability', 'timeFrame': '16 weeks'}, {'measure': 'Injection site reactions', 'timeFrame': '16 weeks'}, {'measure': 'Immunogenicity', 'timeFrame': '16 weeks'}], 'secondaryOutcomes': [{'measure': 'Nerve growth factor levels', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091013&StudyName=Measure%20Exposure%20Of%20Tanezumab%20In%20Healthy%20Volunteers%20When%20Administering%20The%20Drug%20Subcutaneously', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* BMI of 18-30 kg/m2\n* more than 50 kg bodyweight.\n\nExclusion Criteria:\n\n* Pregnant\n* exposure to biologic type drugs within the last 3 months\n* history of allergic or anaphylactic reaction to a biologic drug\n* use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day\n* excessive alcohol use.'}, 'identificationModule': {'nctId': 'NCT00788294', 'briefTitle': 'Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study', 'orgStudyIdInfo': {'id': 'A4091013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '10 mg IV', 'interventionNames': ['Biological: tanezumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5 mg SC', 'interventionNames': ['Biological: tanezumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10 mg SC', 'interventionNames': ['Biological: tanezumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '19 mg SC', 'interventionNames': ['Biological: tanezumab']}], 'interventions': [{'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'Drug solution given intravenously only once at dose of 10 mg', 'armGroupLabels': ['10 mg IV']}, {'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'Drug solution given subcutaneously only once at dose of 5 mg.', 'armGroupLabels': ['5 mg SC']}, {'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'Drug solution given subcutaneously only once at dose of 10 mg.', 'armGroupLabels': ['10 mg SC']}, {'name': 'tanezumab', 'type': 'BIOLOGICAL', 'description': 'Drug solution given subcutaneously only once at dose of 19 mg.', 'armGroupLabels': ['19 mg SC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}