Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
First evaluation of safety, tolerability, pharmacokinetics and the pharmacodynamic effect of BI 11634 on coagulation parameters
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 11634 drinking solution | Experimental | single rising dose |
|
| Placebo | Placebo Comparator |
| |
| BI 11634 tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 11634 drinking solution | Drug |
| ||
| BI 11634 tablet |
| 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 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 hours after drug administration | |
| tmax (time from dosing to maximum measured concentration) | up to 72 hours after drug administration |
Not provided
Inclusion Criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000591017 | N-(1-(5-chloro-1H-benzimidazol-2-yl)-2-methoxyethyl)-3-methyl-4-(3-oxo-4-morpholinyl)benzamide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Placebo | Drug |
|
| AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 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 72 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 72 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 72 hours after drug administration |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 72 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 72 hours after drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 48 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 48 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 48 hours after drug administration |
| Activated partial thromboplastin time (aPTT) ratios between groups | up to 72 hours after drug administration |
| Maximum aPTT prolongation | compared between groups | up to 72 hours after drug administration |
| Maximum international normalized ratio (INR) | compared between groups | up to 72 hours after drug administration |
| % inhibition of endogenous Factor Xa | by Russel's Viper Venom test (RVV) | up to 72 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 72 hours after drug administration |