Recent Updates
Recently added Catalysts

BMS-986189

Phase 1

Severe Sepsis | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 7, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02739373Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of BMS-986189 in Healthy SubjectsPHASE1 COMPLETED 76 — — Apr 18, 2016Dec 14, 2016Feb 7, 20181 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum observed concentration (Cmax)
Day 1 to Day 30
Time of maximum observed concentration (Tmax)
Day 1 to Day 30
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(O-T))
Day 1 to Day 30
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Day 1 to Day 30
Half Life (T-HALF)
Day 1 to Day 30
Total Body Clearance (CLT/F)
Day 1 to Day 30
Apparent volume of distribution at steady state (Vss/F)
Day 1 to Day 30
Deaths leading to discontinuation
Day 1 to Day 30
Adverse events (AEs) leading to discontinuation
Day 1 to Day 30
Serious adverse events (SAEs) leading to discontinuation
Day 1 to Day 30
Lab abnormalities leading to discontinuation
Day 1 to Day 30
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BMS-986189EXPERIMENTALSpecified Dose on Specified Day
PlaceboPLACEBO_COMPARATORSpecified Dose on Specified Day
Interventions
NameTypeDescription
BMS-986189DRUG -
PlaceboOTHER -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy, males and females, 18 to 55 years of age, inclusive * Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive * Women of childbearing potential (WOCBP) must have nega...

Countries:United States
Unlock Eligibility Criteria