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BMS-986120

Phase 1

Healthy Adult Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jul 7, 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-BlindCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02208882Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120PHASE1 COMPLETED 24 — — Aug 1, 2014Feb 1, 2015Jul 7, 20151 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability measured by number of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Up to 168 days
Safety and tolerability measured by percent of subjects experience serious adverse events, deaths, adverse events leading to discontinuation, and potential clinically significant changes in electrocardiogram (ECG) parameters
Up to 168 days
Secondary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Time of maximum observed plasma concentration (Tmax) of BMS-986120, BMT-141464, Midazolam, and 1'hydroxymidazolam
Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
Area under the concentration-time curve from time zero to 24h [AUC(TAU)] of BMS-986120 and BMT-141464
Part A (Days 1-8), Part B/C (Days 1-19), & Part D (Days 1-22)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Panel 1: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified
Panel 2: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified
Panel 3: BMS-986120 or Placebo + MidazolamEXPERIMENTALBMS-986120 or Placebo (multiple dose) + Midazolam (single dose) by mouth as specified
Panel 4: BMS-986120 or PlaceboEXPERIMENTALBMS-986120 or Placebo multiple dose by mouth as specified
Interventions
NameTypeDescription
BMS-986120DRUG -
PlaceboDRUG -
MidazolamDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory det...

Countries:United States
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