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First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in a statistical sense defined)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 11634 | Experimental | multiple rising dose |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 11634 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 10 days after last drug administration | |
| Number of subjects with clinically significant findings in vital signs (blood pressure, pulse rate) | up to 10 days after last drug administration | |
| Number of subjects with clinically significant findings in ECG | up to 10 days after last drug administration | |
| Number of subjects with clinically significant findings laboratory tests | up to 10 days after last drug administration | |
| Assessment of tolerability by investigator on a 4-point scale | up to 10 days after last drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of analyte in plasma) | up to 144 hours after first drug administration | |
| tmax (time from dosing to maximum measured concentration) | up to 144 hours after first drug administration |
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Inclusion Criteria:
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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|
| AUCτ,n (area under the concentration-time curve of analyte in plasma over a uniform dosing interval τ after administration of the n-th dose) | up to 144 hours after first drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 144 hours after first drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 144 hours after first drug administration |
| CLR,t1-t2 (renal clearance of analyte from the time point t1 until the time point t2) | up to 144 hours after first drug administration |
| Cmin,ss (minimum measured concentration of analyte in plasma at steady state over a uniform dosing interval τ) | up to 144 hours after first drug administration |
| Cpre,ss (predose concentration of analyte in plasma at steady state immediately before administration of the next dose) | up to 144 hours after first drug administration |
| λz,ss (terminal rate constant in plasma at steady state) | up to 144 hours after first drug administration |
| t1/2,ss (terminal half-life of analyte in plasma at steady state) | up to 144 hours after first drug administration |
| MRTpo,ss (mean residence time of analyte in the body after multiple oral administrations at steady state) | up to 144 hours after first drug administration |
| CL/F,ss (apparent clearance of analyte in the plasma at steady state following extravascular multiple dose administration) | up to 144 hours after first drug administration |
| Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration) | up to 144 hours after first drug administration |
| PTF (peak-trough fluctuation) | up to 144 hours after first drug administration |
| Cavg (average concentration of analyte in plasma at steady state) | up to 144 hours after first drug administration |
| RA,Cmax (Accumulation ratio of analyte in plasma based on Cmax) | up to 144 hours after first drug administration |
| RA,AUC (Accumulation ratio of analyte in plasma based on AUC) | up to 144 hours after first drug administration |
| Cpre,N (predose concentration of analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered ) | up to 144 hours after first drug administration |
| Activated partial thromboplastin time (aPTT) ratios between groups | up to 144 hours after first drug administration |
| Maximum aPTT prolongation | up to 144 hours after first drug administration |
| Maximum international normalized ratio (INR) | up to 144 hours after first drug administration |
| % inhibition of endogenous Factor Xa | by Russel's Viper Venom test (RVV) | up to 144 hours after first drug administration |
| Maximum prolongation of blood coagulation time | by HepTest® (Haemachem Inc.) | up to 144 hours after first drug administration |
| Percent inhibition of FXa | by COAMATIC© Heparin test (Chromogenix) | up to 144 hours after first drug administration |
| Percent inhibition of thrombin generation by BI 11634 | up to 144 hours after first drug administration |
| Percent peak inhibition of thrombin generation | up to 144 hours after first drug administration |
| Time to maximum inhibition of thrombin generation BI 11634 | up to 144 hours after first drug administration |
| Percent prolongation of lag time | up to 144 hours after first drug administration |