Thrombosis
Conditions
Brief summary
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.
Interventions
DRUGBMS-962212
Intravenous Infusion administration over 2 hours or 5 days
DRUGAspirin
Oral administration
OTHERPlacebo
Oral administration
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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 determinations * Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive \[as calculated by BMI = weight (kg)/ \[height (m)\]2 * This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been randomized / has not been treated). If re-enrolled, the subject must be re-consented * Men, ages 18 to 45 years, inclusive; women, ages 18-45, who are not of child-bearing potential * Women must not be breastfeeding
Exclusion criteria
* Any significant acute or chronic medical illness * Women of child-bearing potential * Current or recent (within 3 months of study drug administration) gastrointestinal disease which by the judgment of the Investigator may increase a subject's risk of gastrointestinal bleeding (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrectomy) * Any major surgery within 12 weeks of study drug administration * History of blood transfusion, clinically significant bleeding event(s), or documented genetic bleeding diathesis or thrombophilia * For Aspirin Containing Arm Participants Only: Known allergy to non-steroidal anti-inflammatory drugs or history of intolerance or abnormal sensitivity to aspirin (e.g gastrointestinal intolerance, bruising or bleeding, aspirin induced breathing difficulties or nasal polyps) Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QRS - The interval from the beginning of the Q wave and the end of the S wave | Up to 8 days | measured by ECG |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed