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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-006184-22 | EudraCT Number | EudraCT |
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To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 163538 XX | Experimental | 1 single dose per subject as oral solution |
|
| Placebo to BI 163538 XX | Placebo Comparator | 1 single dose per subject as oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 163538 XX | Drug | 1 single dose per subject as oral solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events | up to 15 days postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) | up to 96 hours postdose | |
| AUC0-∞ (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity) | up to 96 hours postdose |
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Inclusion criteria:
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 |
|---|---|---|---|---|---|---|
| 1291.1.1 Boehringer Ingelheim Investigational Site | Neuss | Germany |
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| BI 163538 XX |
| Drug |
1 single dose per subject as oral solution |
|
| AUC0-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 96 hours postdose |