drugset / Trial / NCT01535222
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDCO-2010 in Patients Undergoing Elective Coronary Artery Bypass Graft Surgery
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The purpose of this study is to demonstrate that periprocedural infusion of escalating doses of MDCO-2010 is safe and tolerated in patients undergoing elective CABG surgery, to characterize the single dose pharmacokinetics of MDCO-2010, to investigate the effect of MDCO-2010 on pharmacodynamics (biomarkers of fibrinolysis and coagulation parameters), and to investigate the effect on exploratory clinical endpoints of bleeding, transfusion requirements and reexploration.
Timeline
- Start
- 2010-11
- Primary completion
- 2011-05
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MDCO-2010 | Small molecule | 0.0125 mg/kg | Intravenous |
| Subject | MDCO-2010 | Small molecule | 0.025 mg/kg | Intravenous |
| Subject | MDCO-2010 | Small molecule | 0.0625 mg/kg | Intravenous |
| Subject | MDCO-2010 | Small molecule | 0.125 mg/kg | Intravenous |
| Subject | MDCO-2010 | Small molecule | 0.25 mg/kg | Intravenous |