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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

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

BMS-919373 · 1 trial · 1 indication

Phase 1 1
NCT02089061Drug Interaction StatinAcute Coronary Syndromes
COMPLETED26 Analytics
PHASE1COMPLETED
Drug Interaction Statin
Acute Coronary Syndromes
NCT0208906126
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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 to 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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Frequently asked questions about BMS-919373

What is BMS-919373 used for?

BMS-919373 is an investigational small molecule being developed for Acute Coronary Syndromes, a group of conditions related to sudden reduced blood flow to the heart. It is currently in Phase 1 clinical development and has not been approved for any use.

Who makes BMS-919373?

BMS-919373 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical research on this investigational drug for Acute Coronary Syndromes.

What phase is BMS-919373 in?

BMS-919373 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation for Acute Coronary Syndromes.

What clinical trials is BMS-919373 in?

BMS-919373 has one completed Phase 1 clinical trial registered as NCT02089061, titled "Drug Interaction Statin." The trial enrolled 26 participants, included healthy volunteers, and studied the drug in the context of Acute Coronary Syndromes.

Is BMS-919373 FDA approved?

BMS-919373 is not FDA approved. It is an investigational drug in Phase 1 clinical development for Acute Coronary Syndromes. The drug has completed one early-stage trial, but it has not received marketing approval from the FDA or any other regulatory agency.