Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-05-23 @ 6:38 AM
Study NCT ID:
NCT03612557
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010401', 'term': 'Penicillin G Benzathine'}, {'id': 'D010400', 'term': 'Penicillin G'}], 'ancestors': [{'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-08', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration for penicillin G (Cmax)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Time to Cmax (Tmax)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Area under the plasma concentration time curve from time zero to the time of the last measurable concentration (AUClast)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Area under the plasma concentration time curve from time zero extrapolated to infinite time (as data permit)(AUCinf)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Apparent clearance (as data permit) (CL/F)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Apparent volume of distribution (as data permit) (Vz/F)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}, {'measure': 'Terminal half life (as data permit) (t1/2)', 'timeFrame': '0, 3, 6, 12, 24, 36, 48, 144, 312, 480, and 648 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects experiencing an Adverse Event', 'timeFrame': 'Screening up to 28 days after last dose of study medication'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Benzathine benzylpenicillin', 'penicillin G benzathine'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B8441001&StudyName=A+Phase+1%2C+Open-label+Study+To+Investigate+The+Pharmacokinetics+And+Safety+Of+A+Single+Intramuscular+Injection+Of+2%2C400%2C000+Units+Penicillin+G+Benzathine+In+Japanese+Healthy+Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}, {'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B8441001&StudyName=A+Phase+1%2C+Open-label+Study+To+Investigate+The+Pharmacokinetics+And+Safety+Of+A+Single+Intramuscular+Injection+Of+Benzathine+Benzylpenicillin+In+Japanese+Healthy+Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects\n* Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg and \\<100 kg.\n\nExclusion Criteria:\n\n• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).'}, 'identificationModule': {'nctId': 'NCT03612557', 'briefTitle': 'A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects', 'orgStudyIdInfo': {'id': 'B8441001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active treatment arm', 'description': 'penicillin G benzathine treatment', 'interventionNames': ['Drug: penicillin G benzathine']}], 'interventions': [{'name': 'penicillin G benzathine', 'type': 'DRUG', 'otherNames': ['penicillin G', 'benzathine benzylpenicillin'], 'description': '2.4 million units (IM) of benzathine benzylpenicillin', 'armGroupLabels': ['active treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '192-0071', 'city': 'Hachioji-shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'P-one Clinic, Keikokai Medical Corporation'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}