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BMS-754807

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jun 14, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01525823Assessment of Blood Glucose Changes in Healthy Volunteers After BMS-754807 Alone or BMS-754807 With MetforminPHASE1 COMPLETED 26Feb 1, 2012Apr 1, 2012Jun 14, 20121 Australia
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Study Endpoints
Primary Endpoints
Mean difference of the peak plasma glucose concentrations following administration of BMS-754807 alone and following 2 weeks of Metformin administration
On Day 3 and Day 17
Secondary Endpoints
Safety endpoints: AEs and marked clinical laboratory abnormalities
Day -21 to Day 47
Maximum observed plasma concentration (Cmax) of BMS-754807 and M5
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
Time of maximum observed plasma concentration (Tmax) of BMS-754807 and M5
9 timepoints over 24 hours following Day 1 dose and 12 timepoints over 72 hours for the Day 5 dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
BMS-754807 + MetforminEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-754807 (IGR-IR/IR Inhibitor)DRUGTablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
MetforminDRUGTablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects ages 18 to 55 determined with no clinically significant deviation from normal medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory * Women who are not of childbearing potential Exclusion Criteria: * Eviden...

Countries:Australia
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