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BMS-903452

Phase 1

Diabetes | Small molecule | Metabolic |Bristol-Myers Squibb Company|Last Updated: Mar 15, 2012

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01240980Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)PHASE1 COMPLETED 104Nov 1, 2010Jan 1, 2012Mar 15, 20122 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 10 days of study drug administration
Secondary Endpoints
Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism
Within 2 days of study drug administration
Effect on electrocardiographic (ECG) parameters
Within 10 days of study drug administration
Percent urinary recovery (% UR)
Within 10 days of study drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-903452 (0.1 mg) or Placebo - A1EXPERIMENTAL(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - A2EXPERIMENTAL(Healthy Subjects)
BMS-903452 (3.0 mg) or Placebo - A3EXPERIMENTAL(Healthy Subjects)
BMS-903452 (10 mg) or Placebo - A4EXPERIMENTAL(Healthy Subjects)
BMS-903452 (30 mg) or Placebo - A5EXPERIMENTAL(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A6EXPERIMENTAL(Healthy Subjects)
BMS-903452 (120 mg) or Placebo - A7EXPERIMENTAL(Healthy Subjects)
BMS-903452 (0.6 mg) or Placebo - B1EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - B2EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (120 mg) or Placebo - B3EXPERIMENTAL(Subjects with type 2 Diabetes Mellitus)
BMS-903452 (10 mg) or Placebo - A11EXPERIMENTAL(Healthy Subjects)
BMS-903452 (60 mg) or Placebo - A12EXPERIMENTAL(Healthy Subjects)
Interventions
NameTypeDescription
BMS-903452DRUGSolution, Oral, 0.1 mg, once daily, 1 day
PlaceboDRUGSolution, Oral, 0 mg, once daily, 1 day
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Clinically healthy or Clinical diagnosis of Type 2 diabetes on a stable dose of metformin monotherapy Exclusion Criteria: * Type 1 Diabetes * History of significant heart disease * Prior bariatric surgery * Women of childbearing potential

Countries:United States
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