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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001475-20 | EudraCT Number | EudraCT |
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The objective of the single rising dose part (SRD) is to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 1060469 in healthy male subjects. The objective of the food effect part (FE) is to investigate the relative bioavailability of BI 1060469 tablets in healthy male subjects in fed or fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1060469 single rising dose part | Experimental | single rising doses given as tablet |
|
| BI 1060469 food effect part | Experimental | given as tablet fasted and fed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 1060469 | Drug | single rising doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with drug- related adverse events. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of BI 1060469 in plasma) | up to 2 weeks | |
| AUC0-infinity (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 extrapolated to infinity) | up to 2 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1333.1.1 Boehringer Ingelheim Investigational Site | Biberach | Germany |
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| BI 1060469 |
| Drug |
food effect |
|
| BI 1060469 | Drug | single rising doses |
|
| AUC0-tz (area under the concentration-time curve of BI 1060469 in plasma over the time interval from 0 up to the last quantifiable data point) | up to 2 weeks |