Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2026-01-01 @ 12:16 PM
Study NCT ID:
NCT03196557
Status:
COMPLETED
Last Update Posted:
2019-12-06
First Post:
2017-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2008-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2017-06-21', 'studyFirstSubmitQcDate': '2017-06-21', 'lastUpdatePostDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin 1 beta', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Tumor necrosis factor-alpha', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Receptor activator of nuclear factor-kB (RANK)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Receptor activator of nuclear factor-kB ligand (RANKL)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Osteoprotegrin (OPG)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Lipopolysaccharide Induced Cytokine Production', 'timeFrame': 'Up to 32 days', 'description': 'As measured by blood concentration'}, {'measure': 'Cell Populations', 'timeFrame': 'Up to 32 days', 'description': 'As measured by flow cytometry'}, {'measure': 'Oral glucose tolerance test', 'timeFrame': 'Up to 32 days', 'description': 'Assessed by central labortatory'}, {'measure': 'Cortisol', 'timeFrame': 'Up to 32 days', 'description': 'As measured by the level of the hormone cortisol in the blood'}, {'measure': 'Adrenocorticotropic hormone', 'timeFrame': 'Up to 32 days', 'description': 'As measured by the level of the hormone in the blood'}, {'measure': 'Osteocalcin', 'timeFrame': 'Up to 32 days', 'description': 'As measured by blood concentration'}, {'measure': 'N-terminal Pro-Collagen Peptide (PINP)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by blood concentration'}, {'measure': 'Propetide type I C-term Pro-collagen Peptide (CICP)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by blood concentration'}, {'measure': 'Bone-specific alkaline phosphatase', 'timeFrame': 'Up to 32 days', 'description': 'As measured by blood concentration'}, {'measure': 'Urinary deoxypyridinoline', 'timeFrame': 'Up to 32 days', 'description': 'As measured by urine concentration'}, {'measure': 'C Telopeptide of Collagen Type II (CTX-II)', 'timeFrame': 'Up to 32 days', 'description': 'As measured by urine concentration'}, {'measure': 'Calcium', 'timeFrame': 'Up to 32 days', 'description': 'As measured by urine concentration'}, {'measure': 'Creatinine', 'timeFrame': 'Up to 32 days', 'description': 'As measured by urine concentration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Immunoscience']}, 'referencesModule': {'references': [{'pmid': '29534336', 'type': 'DERIVED', 'citation': 'Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacodynamics of Prednisolone in healthy male subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n* Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive\n* Signed informed consent\n\nExclusion Criteria:\n\n* Women\n* Any significant acute or chronic medical illness\n* Current or recent (within 3 months) gastrointestinal disease including peptic ulcer\n\nOther protocol inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03196557', 'briefTitle': 'A Study to Assess the Pharmacodynamics (PD) of Prednisoline in Healthy Male Subject', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Experimental Medicine Study to Assess the Pharmacodynamics Following Administration of Multiple Doses of Prednisolone to Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'IM124-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'Specified dose on specified days', 'interventionNames': ['Drug: Prenisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B', 'description': 'Specified dose on specified days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Prenisolone', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on dose on specified days', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ppd Development', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78759', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}