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BMS-962212

Phase 1

Thrombosis | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Jul 2, 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
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment691
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03197779A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsPHASE1 COMPLETED 691Nov 18, 2013Jan 24, 2017Jul 2, 20173 United States
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Study Endpoints
Primary Endpoints
Adverse Events (AE)
Up to 8 days

measured by incidence

Serious Adverse Events (SAE)
Up to 8 days

measured by incidence

Discontinuation due to AE
Up to 8 days

measured by incidence

Death
Up to 8 days

measured by incidence

AE of clinically significant bleeding
Up to 8 days

measured by incidence

AE of clinically significant infusion reaction
Up to 8 days

measured by incidence

AE of clinically significant vital signs
Up to 8 days

measured by incidence

QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula
Up to 8 days

measured by ECG

QRS - The interval from the beginning of the Q wave and the end of the S wave
Up to 8 days

measured by ECG

PR - The interval from the beginning of the P wave to the beginning of the QRS complex
Up to 8 days

measured by ECG

24-hour cardiac monitoring
Up to 6 days

measured by telemetry

Glomerular filtration rate (GFR)
Up to 8 days

measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation

Cystatin-C
Up to 8 days

measured by serum biomarkers

Neutrophil gelatinase-associated lipocalin (NGAL)
Up to 8 days

measured by urine biomarkers

Monocyte chemoattractant protein-1 (MCP-1)
Up to 8 days

measured by urine biomarkers

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-962212 Two Hour AdministrationEXPERIMENTALIntravenous administered over 2 hours of BMS-962212
BMS-962212 5 Day AdministrationEXPERIMENTALIntravenous administered over 5 days of BMS-962212
BMS-962212 and AspirinEXPERIMENTALBMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin
Placebo and AspirinPLACEBO_COMPARATORPlacebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin
PlaceboPLACEBO_COMPARATORPlacebo intravenous administration
Interventions
NameTypeDescription
BMS-962212DRUGIntravenous Infusion administration over 2 hours or 5 days
AspirinDRUGOral administration
PlaceboOTHEROral administration
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites3

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECG, and clinical laboratory dete...

Countries:United States
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