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To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 14332 CL | Experimental | single rising dose |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 14332 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | up to day 16 | |
| Number of patients with clinically significant findings in vital signs (blood pressure, heart rate) | up to day 16 | |
| Number of patients with clinically significant findings ECG | up to day 16 | |
| Number of patients with clinically significant findings laboratory tests | up to day 16 | |
| Assessment of global tolerability by investigator on a 4-point scale | within 9 to 16 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | up to 192 hours after drug administration | |
| tmax (time from dosing to maximum concentration) | up to 192 hours after drug administration | |
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Inclusion Criteria:
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 192 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | up to 192 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 192 hours after drug administration |
| λz (terminal rate constant in plasma) | up to 192 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | up to 192 hours after drug administration |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 192 hours after drug administration |
| CL/F (total clearance of the analyte in the plasma after extravascular administration) | up to 192 hours after drug administration |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 192 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 120 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 120 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 120 hours after drug administration |
| Change in Dipeptidyl peptidase IV (DDP-IV) activity | up to 192 hours after drug administration |