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Study to investigate safety and tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of BEA 2180 BR
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BEA 2180 BR | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEA 2180 BR | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal findings in physical examination | up to day 42 | |
| Number of subjects with clinically significant changes in vital signs | up to day 42 | |
| Number of subjects with clinically significant changes in 12-lead electrocardiogram | up to day 42 | |
| Number of subjects with clinically significant changes in laboratory parameters | up to day 42 | |
| Changes in effective airway resistance (Reff) | Body plethysmography | up to day 25 |
| Changes in specific effective airway conductance (SGeff) | Body plethysmography | up to day 25 |
| Changes in salivary secretion | up to day 21 | |
| Number of subjects with adverse events | up to day 42 | |
| Assessment of tolerability by the Investigator on a 4-point rating scale | day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the analyte in plasma for several time points | up to day 35 | |
| Time from dosing to maximum concentration in plasma for several time points | up to day 35 | |
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Inclusion Criteria:
Healthy males according to the following criteria (examined at the Screening Visit):
Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
1.1 No finding deviating from normal and of clinical relevance
1.2 No evidence of a clinically relevant concomitant disease
Age ≥30 and ≤55 years
BMI ≥18.5 and BMI < 30 kg/m2 (Body Mass Index)
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria:
Exclusion criteria specific for this study:
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|
| Respimat® | Device |
|
| Area under the concentration-time curve of the analyte in plasma for several time points |
| up to day 35 |
| Amount of analyte that is eliminated in urine for several time points | up to day 34 |
| Fraction of analyte excreted in urine for several time points | up to day 34 |
| Renal clearance of the analyte in plasma for several time points | up to day 34 |
| Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval | up to day 35 |
| Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose | up to day 35 |
| Terminal rate constant in plasma at steady state (λz,ss) | up to day 35 |
| Terminal half-life of the analyte in plasma at steady state (t1/2,ss) | up to day 35 |
| Mean residence time of the analyte in the body after 21 administrations at steady state (MRTih,ss) | up to day 35 |
| apparent clearance of the analyte in the plasma after extravascular administration at steady state (CL/F,ss) | up to day 35 |
| apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss) | up to day 35 |
| Accumulation ratio (RA) of the analyte in plasma after multiple dose administration over a uniform dosing interval τ | up to day 35 |
| Peak trough fluctuation (PTF) | up to day 35 |