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To investigate safety, tolerability, and pharmacokinetics (PK) of single i.v. doses of BI 1744 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1744 CL | Experimental | Single rising dose of BI 1744 CL as intravenous (i.v.) infusion |
|
| 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 | Baseline, Day 10 after drug administration | |
| Number of patients with clinically significant changes in vital signs | Baseline and up to day 10 after drug administration | |
| Number of patients with abnormal changes in 12-lead ECG (electrocardiogram) parameters | Baseline and up to day 10 after drug administration | |
| Number of patients with abnormal changes in laboratory parameters | Baseline and up to day 10 after administration | |
| Number of patients with adverse events | Up to day 10 | |
| Assessment of tolerability by investigator on a 4-point scale | Day 10 after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC (area under the concentration-time curve of the analyte in plasma at different time points) | Up to 48 hours after drug administration | |
| Cmax (maximum measured concentration of the analyte in plasma) | Up to 48 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:
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| ID | Term |
|---|---|
| C549647 | olodaterol |
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|
| tmax (time from dosing to maximum measured concentration) | Up to 48 hours after drug administration |
| %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation) | Up to 48 hours after drug administration |
| λz (terminal rate constant in plasma) | Up to 48 hours after drug administration |
| t1/2 (terminal half-life of the analyte in plasma) | Up to 48 hours after drug administration |
| MRT (mean residence time of the analyte in the body after intravenous administration) | Up to 48 hours after drug administration |
| CL (total clearance of the analyte in plasma after intravascular administration) | Up to 48 hours after drug administration |
| V (apparent volume of distribution at different time points following an intravascular dose) | Up to 48 hours after drug administration |
| Aet1-t2 (amount of analyte eliminated in urine from the time point t1 to time point t2) | Up to 96 hours after drug administration |
| fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2) | Up to 96 hours after drug administration |
| CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2) | Up to 96 hours after drug administration |