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BMS-866949

Phase 1

Depression | Small molecule | Psychiatry |Bristol-Myers Squibb Company|Last Updated: Jan 25, 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-BlindCONTROLLED
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00949767Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy SubjectsPHASE1 COMPLETED 64Jul 1, 2009Mar 1, 2010Jan 25, 20111 Sweden
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Study Endpoints
Primary Endpoints
Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs
up to Day 14 +/- 2 days post-dose
Secondary Endpoints
Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples
Blood samples will be taken up to 144 hour post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
BMS-866949 (Panel 1)EXPERIMENTAL -
BMS-866949 (Panel 2)EXPERIMENTAL -
BMS-866949 (Panel 3)EXPERIMENTAL -
BMS-866949 (Panel 4)EXPERIMENTAL -
BMS-866949 (Panel 5)EXPERIMENTAL -
BMS-866949 (Panel 6)EXPERIMENTAL -
BMS-866949 (Panel 7)EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-866949DRUG(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days
PlaceboDRUG(Matching volume) - Oral Solution, Oral, once 14 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male 18-55 * Women not of child bearing potential, 18-55 Exclusion Criteria: * History of or current treatment for psychiatric illnesses, substance abuse or dependence * History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, ...

Countries:Sweden
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