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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 11634 single rising dose | Experimental | tablet |
|
| BI 11634 cross-over | Experimental | sequence: 1. tablet 2. drinking solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 11634 tablet | Drug |
| ||
| BI 11634 drinking solution |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 10 days after drug administration | |
| Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate) | up to 10 days after drug administration | |
| Number of subjects with clinically significant findings in ECG | up to 10 days after drug administration | |
| Number of subjects with clinically significant findings in laboratory tests | up to 10 days after drug administration | |
| Assessment of tolerability by investigator on a 4-point scale | up to 10 days after drug administration | |
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 24 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 24 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| tmax (time from dosing to maximum measured concentration) | up to 24 hours after drug administration | |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 up to the last quantifiable data point) | up to 24 hours after drug administration |
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Exclusion Criteria:
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| ID | Term |
|---|---|
| C000591017 | N-(1-(5-chloro-1H-benzimidazol-2-yl)-2-methoxyethyl)-3-methyl-4-(3-oxo-4-morpholinyl)benzamide |
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| Drug |
|
| λz (terminal rate constant in plasma) | up to 24 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 24 hours after drug administration |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 24 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 24 hours after drug administration |
| Activated partial thromboplastin time (aPTT) ratios between groups | up to 24 hours after drug administration |
| Maximum aPTT prolongation | up to 24 hours after drug administration |
| % inhibition of endogenous Factor Xa | by Russel's Viper Venom test (RVV) | up to 24 hours after drug administration |
| Maximum international normalized ratio (INR) | compared between groups | up to 24 hours after drug administration |
| Percent inhibition of thrombin generation by BI 11634 | up to 24 hours after drug administration |
| Percent peak inhibition of thrombin generation | up to 24 hours after drug administration |
| Time to maximum inhibition of thrombin generation BI 11634 | up to 24 hours after drug administration |
| Percent prolongation of lag time | up to 24 hours after drug administration |
| Area under the inhibition of the endogenous thrombin generation-time curve | up to 24 hours after drug administration |
| Maximum prolongation of blood coagulation time | by HepTest® (Haemachem Inc.) and COAMATIC® Heparin test (Chromogenix) | up to 24 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 24 hours after drug administration |