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BMS-962212

Phase 1

Thrombosis | Small molecule | Cardiovascular |Bristol-Myers Squibb Company|Last Updated: Jul 2, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment691

FDA Designations

No designations recorded

Clinical trial landscape

BMS-962212 · 1 trial · 1 indication

Phase 1 1
NCT03197779A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy SubjectsThrombosis
COMPLETED691 Analytics
PHASE1COMPLETED
A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects
ThrombosisUnlock trial analytics

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 to 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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Frequently asked questions about BMS-962212

What is BMS-962212 used for?

BMS-962212 is an investigational small molecule being developed by Bristol-Myers Squibb for the treatment of thrombosis, a condition involving blood clot formation. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does BMS-962212 target?

The specific molecular target of BMS-962212 is not disclosed in available information. It is a small molecule being studied for its effects on thrombosis, but its precise mechanism of action has not been publicly detailed.

Who makes BMS-962212?

BMS-962212 is being developed by Bristol-Myers Squibb Company, a global biopharmaceutical company. The company is listed on the New York Stock Exchange under the ticker symbol BMY.

What phase is BMS-962212 in?

BMS-962212 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is BMS-962212 in?

BMS-962212 has one completed Phase 1 clinical trial, identified as NCT03197779. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of short and long intravenous infusions of BMS-962212 in healthy subjects in the United States.

Is BMS-962212 the same as any other drug?

No alternative names for BMS-962212 have been identified. It is referred to solely by its developmental code name, BMS-962212, in clinical trial registries and available scientific literature.