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To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 44847 powder | Experimental | single rising dose reconstituted with natrosol solution |
|
| Placebo | Placebo Comparator | reconstituted with natrosol solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 44847 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to day 12 | |
| Number of patients with clinically significant findings in vital signs (blood pressure, pulse rate) | up to day 12 | |
| Number of patients with clinically significant findings in ECG | up to day 12 | |
| Number of patients with clinically significant laboratory findings | up to day 12 | |
| Assessment of tolerability by the investigator on a 4-point scale | up to day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | up to 96 hours after drug administration | |
| tmax (time from dosing to maximum concentration) | up to 96 hours after drug administration | |
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Inclusion Criteria:
Healthy males according to the following criteria:
Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
Age ≥ 18 and Age ≤ 50 years
BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
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|
| AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
| up to 96 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 96 hours after drug administration |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 96 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 96 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 96 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 96 hours after drug administration |
| CL/F (total clearance of the analyte in the plasma after extravascular administration) | up to 96 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 96 hours after drug administration |
| Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) | up to 72 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 72 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 72 hours after drug administration |
| Area under the plasma glucose concentration time curve | up to 96 hours after drug administration |
| Total amount of glucose excreted in urine | up to 72 hours after drug administration |
| Maximum glucose concentration in plasma | up to 96 hours after drug administration |
| Maximum glucose concentration in urine | up to 72 hours after drug administration |