{ "FullStudy":{ "Rank":217913, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515202", "OrgStudyIdInfo":{ "OrgStudyId":"MB121-009" }, "Organization":{ "OrgFullName":"Bristol-Myers Squibb", "OrgClass":"INDUSTRY" }, "BriefTitle":"Japanese Phase 1 Multiple Ascending Dose Study", "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" }, "StatusModule":{ "StatusVerifiedDate":"December 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"September 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 4, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 5, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bristol-Myers Squibb", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "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" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Type 2 Diabetes Mellitus" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Panel 1: BMS-823778 or Placebo matching BMS-823778", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy Subjects", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BMS-823778", "Drug: Placebo matching with BMS-823778" ] } },{ "ArmGroupLabel":"Panel 2: BMS-823778 or Placebo matching BMS-823778", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy Subjects", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BMS-823778", "Drug: Placebo matching with BMS-823778" ] } },{ "ArmGroupLabel":"Panel 3: BMS-823778 or Placebo matching BMS-823778", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy Subjects", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BMS-823778", "Drug: Placebo matching with BMS-823778" ] } },{ "ArmGroupLabel":"Panel 4: BMS-823778 or Placebo matching BMS-823778", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects with T2DM", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BMS-823778", "Drug: Placebo matching with BMS-823778" ] } },{ "ArmGroupLabel":"Panel 5: BMS-823778 or Placebo matching BMS-823778", "ArmGroupType":"Experimental", "ArmGroupDescription":"Subjects with T2DM", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: BMS-823778", "Drug: Placebo matching with BMS-823778" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"BMS-823778", "InterventionDescription":"Capsules, Oral, 2 mg, Once daily, 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Panel 1: BMS-823778 or Placebo matching BMS-823778", "Panel 4: BMS-823778 or Placebo matching BMS-823778" ] } },{ "InterventionType":"Drug", "InterventionName":"BMS-823778", "InterventionDescription":"Capsules, Oral, 12 mg, Once daily, 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Panel 2: BMS-823778 or Placebo matching BMS-823778" ] } },{ "InterventionType":"Drug", "InterventionName":"BMS-823778", "InterventionDescription":"Capsules, Oral, 25 mg, Once daily, 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Panel 3: BMS-823778 or Placebo matching BMS-823778" ] } },{ "InterventionType":"Drug", "InterventionName":"BMS-823778", "InterventionDescription":"Capsules, Oral, 15 mg, Once daily, 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Panel 5: BMS-823778 or Placebo matching BMS-823778" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo matching with BMS-823778", "InterventionDescription":"Capsules, Oral, 0 mg, Once daily, 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "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" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests", "PrimaryOutcomeTimeFrame":"Up to Day 21" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration", "SecondaryOutcomeTimeFrame":"Up to Day 21" },{ "SecondaryOutcomeMeasure":"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)", "SecondaryOutcomeDescription":"HPA = Hypothalamic-pituitary-adrenal\nDHEA-S = Dehydroepiandrosterone-sulphate\nACTH = adrenocorticotropic hormone", "SecondaryOutcomeTimeFrame":"Up to Day 21" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nJapanese 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\nPatient who is taking any medication for T2DM\nSymptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial\nInsulin therapy within one year of screening", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"65 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bristol-Myers Squibb", "OverallOfficialAffiliation":"Bristol-Myers Squibb", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Local Institution", "LocationCity":"Hachioji-Shi", "LocationState":"Tokyo", "LocationZip":"1920071", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Investigator Inquiry form", "SeeAlsoLinkURL":"http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003920", "ConditionMeshTerm":"Diabetes Mellitus" },{ "ConditionMeshId":"D000003924", "ConditionMeshTerm":"Diabetes Mellitus, Type 2" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000044882", "ConditionAncestorTerm":"Glucose Metabolism Disorders" },{ "ConditionAncestorId":"D000008659", "ConditionAncestorTerm":"Metabolic Diseases" },{ "ConditionAncestorId":"D000004700", "ConditionAncestorTerm":"Endocrine System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5702", "ConditionBrowseLeafName":"Diabetes Mellitus, Type 2", "ConditionBrowseLeafAsFound":"Type 2 Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5698", "ConditionBrowseLeafName":"Diabetes Mellitus", "ConditionBrowseLeafAsFound":"Diabetes Mellitus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10222", "ConditionBrowseLeafName":"Metabolic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23990", "ConditionBrowseLeafName":"Glucose Metabolism Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6445", "ConditionBrowseLeafName":"Endocrine System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"BC19", "ConditionBrowseBranchName":"Gland and Hormone Related Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }