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BMS-986147

Phase 1

Healthy | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 19, 2015

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-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02293629A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy SubjectsPHASE1 COMPLETED 8 — — Oct 1, 2014Nov 1, 2014May 19, 20151 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Up to 30 days post last dose of study drug

Adverse event (AE)

Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
Up to 30 days post last dose of study drug
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelFACTORIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
A1: BMS-986147 or Placebo matching BMS-986147PLACEBO_COMPARATORSingle oral dose as specified
A2: BMS-986147 or Placebo matching BMS-986147PLACEBO_COMPARATORSingle oral dose as specified
A3: BMS-986147 or Placebo matching BMS-986147PLACEBO_COMPARATORSingle oral dose as specified
B1: BMS-986147 or Placebo matching BMS-986147ACTIVE_COMPARATORDaily oral dose as specified
B2: BMS-986147 or Placebo matching BMS-986147ACTIVE_COMPARATORDaily oral dose as specified
Interventions
NameTypeDescription
BMS-986147DRUG -
Placebo matching BMS-986147DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy men and women, ages 18 to 45 years * Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory e...

Countries:United States
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