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BMS 986141

Phase 1

Atherothrombotic Diseases | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Feb 23, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02957448A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy SubjectsPHASE1 COMPLETED 16 — — Nov 1, 2016Jan 1, 2017Feb 23, 2017 - —
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Days 1-22
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Days 1-22
Secondary Endpoints
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Screening- until 30 days after discontinuation of dosing or subject's participation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
BMS 986141 and RifampinEXPERIMENTAL -
Interventions
NameTypeDescription
BMS 986141DRUGTwo single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
RifampinDRUGTwo single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: 1. Signed Informed Consent 2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters. 3. Subjects with b...

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