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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000926-23 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, pharmacokinetics including posology, and pharmacodynamics of multiple rising doses of BI 1021958 in otherwise healthy mild asthmatic subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1021958 qd | Experimental | Multiple rising dose |
|
| Placebo to BI 1021958 qd | Placebo Comparator | Matching placebo as tablets |
|
| BI 1021958 bid | Experimental | Multiple rising dose |
|
| Placebo to BI 1021958 bid | Placebo Comparator | Matching palcebo as tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 1021958 qd | Drug | tablet |
| |
| BI 1021958 bid |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with drug-related adverse events | up to day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 481:30 h | |
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) | up to 481:30 h | |
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Inclusion criteria:
1. Healthy male and female subjects ofn non child-bearing potential
Exclusion criteria:
1. Any relevant deviation from healthy conditions except mild controlled asthma
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1310.2.1 Boehringer Ingelheim Investigational Site | Gauting | Germany |
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| Drug |
tablets |
|
| Placebo to BI 1021958 bid | Drug | tablets |
|
| BI 1021958 qd | Drug | tablet |
|
| AUCt,1 (area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose) |
| up to 481:30 h |
| AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing interval) | up to 481:30 h |
| AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 481:30 h |
| Cpre,N (predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered | up to 481:30 h |
| terminal rate constant in plasma | up to 481:30 h |
| MRTpo (mean residence time of the analyte in the body after oral administration) | up to 481:30 h |
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
| tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state) | up to 481:30 h |
| Cmin,ss (minimum concentration of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) | up to 481:30 h |
| terminal rate constant in plasma at steady state | up to 481:30 h |
| t1/2,ss (terminal half-life of the analyte in plasma at steady state) | up to 481:30 h |
| MRTpo,ss (mean residence time of the analyte in the body at steady state after oral administration) | up to 481:30 h |
| CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration) | up to 481:30 h |
| Vz/F,ss (apparent volume of distribution during the terminal phase at steady state following extravascular administration) | up to 481:30 h |
| Cavg (average concentration) | up to 481:30 h |
| PTF (peak trough fluctuation) | up to 481:30 h |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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