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BMS-779788

Phase 1

Atherosclerosis | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Feb 23, 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_CONTROLLED
Total Trials1
Total Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00836602Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy SubjectsPHASE1 COMPLETED 25Feb 1, 2009Jul 1, 2009Feb 23, 20111 Australia
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Study Endpoints
Primary Endpoints
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
8 times within 27 days of the first dose
Secondary Endpoints
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
After each dose panel
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BMS-779788 or Placebo (Arm 1)ACTIVE_COMPARATOR -
BMS-779788 or Placebo (Arm 2)ACTIVE_COMPARATOR -
BMS-779788 or Placebo (Arm 3)ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
BMS-779788DRUGOral Solution, Oral, 1 mg, Once daily, 7 days
PlaceboDRUGOral Solution, Oral, 0 mg, Once daily, 7 days
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women (not of child bearing potential) ages 18 to 45 * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations Exclusion Criteria: * Women of child bearin...

Countries:Australia
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