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The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIX 1 XX - single rising dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIX 1 XX - single rising dose | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 3 months | |
| Number of subjects with abnormal changes in laboratory parameters | up to 8 days after last drug administration | |
| Change in impedance cardiography | up to 30 minutes after drug administration | |
| Change in cutaneous microcirculation | up to 30 minutes after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change in airway resistance (Raw) after methacholine challenge | up to 30 minutes after drug administration | |
| Change in specific conductance (sGaw) after methacholine challenge | up to 30 minutes after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| AUC (Area under the concentration-time curve of the analyte in plasma) | up to 168 hours after drug administration |
| Cmax (Maximum measured concentration of the analyte in plasma) | up to 168 hours after drug administration |
| tmax (Time from dosing to the maximum concentration of the analyte in plasma) | up to 168 hours after drug administration |
| Ae (Amount of analyte that is eliminated in urine) | up to 48 hours after drug administration |
| MRT (Mean residence time of the analyte in the body) | up to 168 hours after drug administration |
| t½ (Terminal half-life of the analyte in plasma) | up to 168 hours after drug administration |
| CL/F(Apparent clearance of the analyte in plasma following extravascular administration) | up to 168 hours after drug administration |