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To investigate safety, tolerability, and pharmacokinetics of BI 11054
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 11054 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 11054 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant findings in physical examination | up to 18 days after drug administration | |
| Number of subjects with clinically significant findings in vital signs | blood pressure (BP), pulse rate (PR), respiratory rate (RR) | up to 18 days after drug administration |
| Number of subjects with clinically significant findings in orthostasis tests | up to 24 hours after drug administration | |
| Number of subjects with clinically significant findings in laboratory tests | up to 18 days after drug administration | |
| Number of subjects with clinically significant findings in additional safety laboratory tests | cyclic adenosine monophosphate (cAMP) and potassium | up to 24 hours after drug administration |
| Number of subjects with clinically significant changes in body temperature | up to 24 hours after drug administration | |
| Number of subjects with clinically significant findings in electrocardiogram (ECG) | up to 18 days after drug administration | |
| Number of subjects with adverse events | up to 18 days after drug administration | |
| Number of subjects with findings of oropharyngeal inspection |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 96 hours | |
| tmax (time from dosing to maximum measured concentration) | up to 96 hours | |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable analyte plasma concentration) |
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Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
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|
| up to 24 hours after drug administration |
| Number of subjects with findings of pulmonary auscultation | up to 24 hours after drug administration |
| Airway resistance (Raw) | measured by body plethysmography | up to 24 hours after drug administration |
| Global tolerability assessed by investigator on a 4-point scale | up to 18 days after drug administration |
| up to 96 hours |
| AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval from time t1 to time t2) | up to 96 hours |
| 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 |
| %AUCtz-∞ (percentage of the AUCtz-∞ that is obtained by extrapolation) | up to 96 hours |
| λz (terminal rate constant in plasma) | up to 96 hours |
| t1/2 (terminal half-life of the analyte in plasma) | up to 96 hours |
| MRTih (mean residence time of the analyte in the body after inhalation) | up to 96 hours |
| CL/F (apparent clearance of the analyte in plasma after extravascular administration) | up to 96 hours |
| Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) | up to 96 hours |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | up to 96 hours |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | up to 96 hours |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | up to 96 hours |