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Study to assess the tolerability of BIBT 986 BS after intravenous infusions of 0.1, 0.3, 1.0, 2.5, 5.0, and 10 mg, to assess the pharmacokinetics of BIBT 986 BS after intravenous infusion and to assess the effect of BIBT 986 BS on blood coagulation parameters
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIBT 986 BS - single rising dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIBT 986 BS - single rising dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after single dose administration) | up to 48 hours after start of infusion | |
| AUC0-tz (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration after single dose administration) | up to 48 hours after start of infusion | |
| C29 (plasma concentration of BIBT 986 BS at the end of infusion) | 29 minutes after start of infusion | |
| t1/2 (Terminal half-life of the analyte in plasma after single dose administration) | up to 48 hours after start of infusion | |
| CL (Total clearance of the analyte in plasma following intravascular administration) | up to 48 hours after start of infusion | |
| Vss (Apparent volume of distribution at steady state following intravascular administration) | up to 48 hours after start of infusion | |
| urinary excretion of BIBT 986 BS | up to 48 hours after start of infusion | |
| CLR (Renal clearance of the analyte in plasma following intravascular administration) | up to 48 hours after start of infusion | |
| MRT (Mean residence time of drug molecules in the body after intravascular administration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| up to 48 hours after start of infusion |
| Change in activated partial thromboplastin time (aPTT) | up to 48 hours after start of infusion |
| Change in International Normalised Ratio (INR) | up to 48 hours after start of infusion |
| Change in ecarin clotting time (ECT) | up to 48 hours after start of infusion |
| Change in thrombin time (TT) | up to 48 hours after start of infusion |
| Number of patients with clinically significant findings in vital signs | pulse rate, blood pressure | up to 48 hours after start of infusion |
| Number of patients with clinically significant findings in electrocardiogram | up to 48 hours after start of infusion |
| Number of patients with clinically significant findings in laboratory tests | up to 48 hours after start of infusion |
| Number of patients with adverse events | up to 48 hours after start of infusion |
| Number of patients with histamine in blood | up to 48 hours after start of infusion |