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To investigate safety, tolerability, pharmacokinetics and pharmacodynamics of BI 1744 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL multiple rising doses | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BI 1744 CL medium dose, females | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1744 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically significant changes in physical examination | Baseline, day 32 (end-of-study examination) | |
| Number of patients with clinically significant changes in vital signs | Baseline, up to day 32 | |
| Number of patients with clinically significant changes in 12-lead ECG (Electrocardiogram) | Baseline, up to day 32 | |
| Number of patients with abnormal changes in laboratory tests | Baseline, up to day 32 | |
| Changes in airway resistance (Raw) measured by body plethysmography | Baseline, up to day 32 | |
| Changes in tremormetry parameters | Baseline, up to day 32 | |
| Number of patients with adverse events | Up to day 32 | |
| Assessment of tolerability by the investigator on a 4-point scale | Day 32 (end-of-study examination) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum concentration of the analyte in plasma) | Up to 408 hours after drug administration | |
| tmax (time from dosing to maximum concentration) | Up to 408 hours after drug administration | |
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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:
For female subjects:
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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| Drug |
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| AUC (area under the concentration-time curve of the analyte in plasma at different time points) |
| Up to 408 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 384 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | Up to 384 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) | Up to 408 hours after drug administration |
| λz (terminal rate constant of the analyte in plasma) | Up to 408 hours after drug administration |
| t½ (terminal half-life of the analyte in plasma) | Up to 408 hours after drug administration |
| MRTih (mean residence time of the analyte in the body after inhalation) | Up to 408 hours after drug administration |
| CL/F (apparent clearance of the analyte in the plasma after extravascular administration) | Up to 408 hours after drug administration |
| Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose) | Up to 408 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 until the time point t2) | Up to 408 hours after drug administration |
| RA,Cmax,14 based on Cmax (Accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ) | Up to 408 hours after drug administration |
| RA,AUC,14 based on AUC0-τ | Up to 408 hours after drug administration |
| Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ) | Up to 408 hours after drug administration |
| Cpre,ss (predose concentration of the analyte in plasma at steady state immediately before administration of the next dose) | Up to 408 hours after drug administration |
| Linearity Index (LI) | Up to 408 hours after drug administration |