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To investigate safety, tolerability, and pharmacokinetics of BI 1744 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL single rising doses | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with abnormal findings in physical examination | 12 days after drug administration | |
| Number of patients with clinically significant changes in vital signs | Baseline, up to 12 days after drug administration | |
| Change in orthostasis test parameters | Baseline, up to 24 hours after drug administration | |
| Number of patients with abnormal changes in laboratory parameters | Baseline, up to 12 days after drug administration | |
| Change in oral body temperature | Baseline, up to 24 hours after drug administration | |
| Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters | Baseline, up to 12 days after drug administration | |
| Number of patients with adverse events | Up to 12 days | |
| Change in tremormetry parameters | Baseline, up to 24 hours after drug administration | |
| Number of patients with abnormal findings of oropharyngeal inspection | Baseline, up to 24 hours after drug administration | |
| Number of patients with abnormal findings of pulmonary auscultation |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to the time of the last quantifiable data point (AUC0-tz) | Up to 96 hours after drug administration | |
| Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 to 24 hours (AUC0-24) |
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Inclusion Criteria:
Exclusion Criteria:
The following exclusion criteria were specific for this study due to the known class side effect profile of ß2-mimetics:
For female subjects:
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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|
| Baseline, up to 24 hours after drug administration |
| Change in airway resistance (Raw), as measured by body plethysmography | Baseline, up to 24 hours after drug administration |
| Assessment of tolerability by investigator on a 4-point scale | 12 days after drug administration |
| Up to 96 hours after drug administration |
| Maximum concentration of BI 1744 CL in plasma (Cmax) | Up to 96 hours after drug administration |
| Time from dosing to maximum concentration (tmax) | Up to 96 hours after drug administration |
| Amount of BI 1744 CLeliminated in urine from the time point t1 to time point t2 (Aet1-t2) | Up to 96 hours after drug administration |
| Fraction of BI 1744 CL eliminated in urine from time point t1 to time point t2 (fet1-t2) | Up to 96 hours after drug administration |
| Renal clearance of BI 1744 CL from 0 to 24 hours (CLR,0-24) | Up to 24 hours after drug administration |
| Terminal rate constant of BI 1744 CL in plasma (λz) | Up to 96 hours after drug administration |
| Terminal half-life of BI 1744 CL in plasma (t½) | Up to 96 hours after drug administration |
| Area under the concentration-time curve of BI 1744 CL in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 96 hours after drug administration |
| AUC0-tz over AUC0-∞ (%AUC0-tz) | Up to 96 hours after drug administration |
| Mean residence time of BI 1744 CL in the body after inhalation (MRTih) | Up to 96 hours after drug administration |
| Apparent clearance of BI 1744 CL in the plasma after extravascular administration (CL/F) | Up to 96 hours after drug administration |
| Apparent volume of distribution of BI 1744 CL during the terminal phase λz following an extravascular dose (Vz/F) | Up to 96 hours after drug administration |