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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002868-88 | EudraCT Number | EudraCT |
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To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 BI 1181181 single rising dose part | Experimental | single rising doses of BI 1181181 |
|
| 2 BI 1181181 bioavailability part | Experimental | bioavailability, food effect part of BI 11881181 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1181181 | Drug | single dose (low to high dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number (%) of subjects with drug-related adverse events (AEs) | up to 72 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) | up to 72 h | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 h |
| Measure | Description | Time Frame |
|---|---|---|
| Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration) | up to 72 h | |
| Cmax (maximum measured concentration of the analyte in plasma) | up to 72 h |
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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 |
|---|---|---|---|---|---|---|
| 1344.1.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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| BI 1181181, R |
| Drug |
powder for oral solution |
|
| BI 1181181, T2 | Drug | tablet, fasted |
|
| Placebo to BI 1181181 | Drug | Placebo to BI 1181181 |
|
| BI 1181181, T1 | Drug | tablet, fed |
|
| tmax (time from dosing to maximum measured concentration of the analyte in plasma) | up to 72 h |
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) | up to 72 h |
| t1/2 (terminal half-life of the analyte in plasma) | up to 72 h |