Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-02 @ 1:26 AM
Study NCT ID:
NCT01288157
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2010-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C529000', 'term': 'golimumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-26', 'studyFirstSubmitDate': '2010-11-22', 'studyFirstSubmitQcDate': '2011-02-01', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (area under the plasma concentration versus time curve [AUC] and Peak Plasma Concentration [Cmax]) of golimumab in Chinese male subjects', 'timeFrame': 'Day 71 (Week 11)'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Day 71'}, {'measure': 'Immunogenicity of golimumab, as measured by antibodies to golimumab', 'timeFrame': 'Day 71'}]}, 'conditionsModule': {'keywords': ['healthy', 'adult', 'Chinese', 'male', 'Simponi', 'CNTO 148'], 'conditions': ['Healthy Adult Chinese Males']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics of golimumab in Chinese male participants.', 'detailedDescription': 'This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi). The study population will consist of 24 healthy male participants in China. Subjects will receive a single dose of either 50 mg or 100 mg golimumab. Subjects will be in the study for up to 14 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (eg, blood pressure), and the occurrence and severity of adverse events. A single dose of 50 mg or 100 mg golimumab as a subcutaneous injection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have no clinically relevant abnormalities\n* non-smoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.\n\nExclusion Criteria:\n\n* Have or had a history of clinically significant, severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease\n* Have any underlying physical or psychological medical condition\n* Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.'}, 'identificationModule': {'nctId': 'NCT01288157', 'briefTitle': 'A Study of the Pharmacokinetics of Golimumab in Chinese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Randomized, Open-label Study to Evaluate the Pharmacokinetics of a Single Subcutaneous Administration of 50 mg or 100 mg Golimumab in a Pre-filled Syringe Formulation to Healthy Male Chinese Subjects', 'orgStudyIdInfo': {'id': 'CR016273'}, 'secondaryIdInfos': [{'id': 'C0524T30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'Golimumab Single dose of 50 mg subcutaneously', 'interventionNames': ['Drug: Golimumab']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'Golimumab Single dose of 100 mg subcutaneously', 'interventionNames': ['Drug: Golimumab']}], 'interventions': [{'name': 'Golimumab', 'type': 'DRUG', 'description': 'Single dose of 100 mg subcutaneously', 'armGroupLabels': ['002']}, {'name': 'Golimumab', 'type': 'DRUG', 'description': 'Single dose of 50 mg subcutaneously', 'armGroupLabels': ['001']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Centocor, Inc. Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centocor, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centocor, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}