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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics following increasing doses of 2 h (Part A) and 5 day (Part B) continuous IV infusions of BMS-962212 in healthy subjects across the expected pharmacodynamic dose range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-962212 Two Hour Administration | Experimental | Intravenous administered over 2 hours of BMS-962212 |
|
| BMS-962212 5 Day Administration | Experimental | Intravenous administered over 5 days of BMS-962212 |
|
| BMS-962212 and Aspirin | Experimental | BMS-962212 intravenous administration, followed by aspirin oral administration, then combination administration of BMS-962212 and aspirin |
|
| Placebo and Aspirin | Placebo Comparator | Placebo intravenous administration, followed by aspirin, then combination administration of placebo and aspirin |
|
| Placebo | Placebo Comparator | Placebo intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-962212 | Drug | Intravenous Infusion administration over 2 hours or 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | measured by incidence | Up to 8 days |
| Serious Adverse Events (SAE) | measured by incidence | Up to 8 days |
| Discontinuation due to AE | measured by incidence | Up to 8 days |
| Death | measured by incidence | Up to 8 days |
| AE of clinically significant bleeding | measured by incidence | Up to 8 days |
| AE of clinically significant infusion reaction | measured by incidence | Up to 8 days |
| AE of clinically significant vital signs | measured by incidence | Up to 8 days |
| QTcF intervals - QT interval corrected for heart rate according to Fridericia's formula | measured by ECG | Up to 8 days |
| QRS - The interval from the beginning of the Q wave and the end of the S wave |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply](streamdown:incomplete-link)
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wcct Global, Llc | Cypress | California | 90630 | United States | ||
| California Clinical Trials Medical Group |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Aspirin | Drug | Oral administration |
|
| Placebo | Other | Oral administration |
|
measured by ECG
| Up to 8 days |
| PR - The interval from the beginning of the P wave to the beginning of the QRS complex | measured by ECG | Up to 8 days |
| 24-hour cardiac monitoring | measured by telemetry | Up to 6 days |
| Glomerular filtration rate (GFR) | measured by iohexol administration plasma clearance and the Chronic Kidney Disease-Epidemiology Collaborative Group (CKD EPI) equation | Up to 8 days |
| Cystatin-C | measured by serum biomarkers | Up to 8 days |
| Neutrophil gelatinase-associated lipocalin (NGAL) | measured by urine biomarkers | Up to 8 days |
| Monocyte chemoattractant protein-1 (MCP-1) | measured by urine biomarkers | Up to 8 days |
| Glendale |
| California |
| 91206 |
| United States |
| Parexel International - Baltimore Epcu | Baltimore | Maryland | 21225 | United States |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000625743 | BMS-962212 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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