Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT01515202
Status:
COMPLETED
Last Update Posted:
2012-12-05
First Post:
2012-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Japanese Phase 1 Multiple Ascending Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624964', 'term': 'BMS-823778'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-04', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests', 'timeFrame': 'Up to Day 21'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration', 'timeFrame': 'Up to Day 21'}, {'measure': 'Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione)', 'timeFrame': 'Up to Day 21', 'description': '* HPA = Hypothalamic-pituitary-adrenal\n* DHEA-S = Dehydroepiandrosterone-sulphate\n* ACTH = adrenocorticotropic hormone'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.', 'detailedDescription': 'MAD study - Multiple Ascending Dose study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese patients with Type 2 Diabetes Mellitus (T2DM) \\[Fasting glucose \\< 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)\\] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years\n\nExclusion Criteria:\n\n* Patient who is taking any medication for T2DM\n* Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial\n* Insulin therapy within one year of screening'}, 'identificationModule': {'nctId': 'NCT01515202', 'briefTitle': 'Japanese Phase 1 Multiple Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blinded, Multiple Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-823778 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'MB121-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel 1: BMS-823778 or Placebo matching BMS-823778', 'description': 'Healthy Subjects', 'interventionNames': ['Drug: BMS-823778', 'Drug: Placebo matching with BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: BMS-823778 or Placebo matching BMS-823778', 'description': 'Healthy Subjects', 'interventionNames': ['Drug: BMS-823778', 'Drug: Placebo matching with BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 3: BMS-823778 or Placebo matching BMS-823778', 'description': 'Healthy Subjects', 'interventionNames': ['Drug: BMS-823778', 'Drug: Placebo matching with BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 4: BMS-823778 or Placebo matching BMS-823778', 'description': 'Subjects with T2DM', 'interventionNames': ['Drug: BMS-823778', 'Drug: Placebo matching with BMS-823778']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 5: BMS-823778 or Placebo matching BMS-823778', 'description': 'Subjects with T2DM', 'interventionNames': ['Drug: BMS-823778', 'Drug: Placebo matching with BMS-823778']}], 'interventions': [{'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 2 mg, Once daily, 14 days', 'armGroupLabels': ['Panel 1: BMS-823778 or Placebo matching BMS-823778', 'Panel 4: BMS-823778 or Placebo matching BMS-823778']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 12 mg, Once daily, 14 days', 'armGroupLabels': ['Panel 2: BMS-823778 or Placebo matching BMS-823778']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 25 mg, Once daily, 14 days', 'armGroupLabels': ['Panel 3: BMS-823778 or Placebo matching BMS-823778']}, {'name': 'BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 15 mg, Once daily, 14 days', 'armGroupLabels': ['Panel 5: BMS-823778 or Placebo matching BMS-823778']}, {'name': 'Placebo matching with BMS-823778', 'type': 'DRUG', 'description': 'Capsules, Oral, 0 mg, Once daily, 14 days', 'armGroupLabels': ['Panel 1: BMS-823778 or Placebo matching BMS-823778', 'Panel 2: BMS-823778 or Placebo matching BMS-823778', 'Panel 3: BMS-823778 or Placebo matching BMS-823778', 'Panel 4: BMS-823778 or Placebo matching BMS-823778', 'Panel 5: BMS-823778 or Placebo matching BMS-823778']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1920071', 'city': 'Hachioji-Shi', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Local Institution'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}