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BMS-820132

Phase 1

Diabetes Mellitus, Non-Insulin-Dependent | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Mar 9, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01105429Single Ascending Dose Study of BMS-820132 in Patients With Type 2 DiabetesPHASE1 COMPLETED 56 — — May 1, 2010Oct 1, 2010Mar 9, 20113 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments
Within 5 days of study drug administration
Secondary Endpoints
Exposure to the investigational drug and its metabolites
Within 2 days after study drug administration
Pharmacodynamic activity of the investigational drug on biomarkers
Within 2 days after study drug administration
Excretion of the investigational drug and metabolites from the body
Within 2 days after study drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-820132 (0.3 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (1.0 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (3 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (10 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (30 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (75 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (150 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (300 mg) or PlaceboACTIVE_COMPARATOR -
BMS-820132 (TBD) or PlaceboACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BMS-820132DRUGOral Solution, Oral, 0.3 mg, once daily, 1 day
PlaceboDRUGOral Solution, Oral, 0mg, once daily, 1 day
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Males and females of childbearing potential (willing to use an acceptable method of contraception), or females of non-childbearing potential (i.e., post-menopausal or surgically sterile) * Diagnosis of type 2 diabetes treated with metformin monotherapy on a stable regimen for ...

Countries:United States
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