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BMS-919373

Phase 1

Acute Coronary Syndromes | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Aug 15, 2014

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02089061Drug Interaction StatinPHASE1 COMPLETED 26 — — Mar 1, 2014May 1, 2014Aug 15, 2014 - —
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin
26 timepoints up to day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
Secondary Endpoints
Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin
28 timepoints up to day 10
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
Cohort 1: Rosuvastatin + BMS-919373EXPERIMENTALRosuvastatin 10 mg tablet orally once for Day 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
Cohort 2: Atorvastatin + BMS-919373EXPERIMENTALAtorvastatin 40 mg tablet once for Days 1 and 5 BMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension
Interventions
NameTypeDescription
BMS-919373DRUG -
RosuvastatinDRUG -
AtorvastatinDRUG -
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Signed Written Informed Consent form * Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examinatio...

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