Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-01-01 @ 3:39 PM
Study NCT ID:
NCT01081704
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2010-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069549', 'term': 'Ustekinumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, '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': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-26', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-03-04', 'lastUpdatePostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine what the body does to ustekinumab (pharmacokinetics) in Chinese Male participants.', 'timeFrame': 'Week 16'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of ustekinumab by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events', 'timeFrame': 'Week 16'}, {'measure': 'Immune response (immunogenicity) of ustekinumab', 'timeFrame': 'Week 16'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy volunteer', 'Chinese male', 'Stelara'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23512638', 'type': 'DERIVED', 'citation': 'Zhu Y, Wang Q, Frederick B, Bouman-Thio E, Marini JC, Keen M, Petty KJ, Davis HM, Zhou H. Comparison of the pharmacokinetics of subcutaneous ustekinumab between Chinese and non-Chinese healthy male subjects across two Phase 1 studies. Clin Drug Investig. 2013 Apr;33(4):291-301. doi: 10.1007/s40261-013-0072-2.'}]}, 'descriptionModule': {'briefSummary': 'A study of the pharmacokinetics of ustekinumab in Chinese male subjects.', '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 ustekinumab (Stelara). The study population will consist of 24 healthy male participants in China. Participants will receive a single dose of either 45mg or 90 mg ustekinumab. Participants will be in the study for up to 16 weeks. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. A single dose of 45 mg or 90 mg ustekinumab.'}, '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\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': 'NCT01081704', 'briefTitle': 'A Study of the Pharmacokinetics of Ustekinumab in Chinese Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Centocor, Inc.'}, 'officialTitle': 'A Study to Evaluate the Pharmacokinetics of Ustekinumab Following a Single Subcutaneous Administration of 45 mg or 90 mg to Healthy, Chinese, Male Subjects', 'orgStudyIdInfo': {'id': 'CR016207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '001', 'description': 'ustekinumab Single dose of 45 mg subcutaneous injection', 'interventionNames': ['Drug: ustekinumab']}, {'type': 'EXPERIMENTAL', 'label': '002', 'description': 'ustekinumab Single dose of 90 mg subcutaneous injection', 'interventionNames': ['Drug: ustekinumab']}], 'interventions': [{'name': 'ustekinumab', 'type': 'DRUG', 'description': 'Single dose of 45 mg subcutaneous injection', 'armGroupLabels': ['001']}, {'name': 'ustekinumab', 'type': 'DRUG', 'description': 'Single dose of 90 mg subcutaneous injection', 'armGroupLabels': ['002']}]}, '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'}}}}