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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002560-24 | EudraCT Number | EudraCT |
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This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI144807 | Experimental | Subjects receive a single oral dose of BI144807solution |
|
| Placebo | Placebo Comparator | Subjects receive a single oral dose of placebo solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 144807 Placebo | Drug | Placebo that represents BI drug |
| |
| BI 144807 |
| Measure | Description | Time Frame |
|---|---|---|
| All adverse events | up to 14 days postdose | |
| Number of participants with clinically significant changes in vital signs | up to 14 days postdose | |
| Number of participants with clinically significant changes in ECG | up to 14 days postdose | |
| Number of participants with clinically significant changes in laboratory tests | up to 14 days postdose | |
| Number of participants with clinically significant changes in physical examination | up to 14 days postdose | |
| Number of participants tolerating BI 144807 | up to 14 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72h postdose | |
| tmax (time from dosing to maximum measured concentration) | up to 72h postdose | |
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Inclusion criteria:
1. healthy male subjects
Exclusion criteria:
1. any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1313.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| Drug |
single dose (low to high dose) |
|
| AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) |
| up to 72h postdose |
| AUC(0-tz) (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) | up to 72h postdose |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72h postdose |