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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002482-30 | EudraCT Number | EudraCT |
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The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of repeated rising doses of BI 1181181, given once daily over 10 days. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1181181.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1181181 healthy young | Experimental | Medium doses as tablets q.d. for 10 days |
|
| BI 1181181 healthy elderly | Experimental | Medium doses as tablets q.d. for 10 days |
|
| Matching placebo in healthy young | Placebo Comparator | Matching placebo for 10 days |
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| Matching placebo in healthy elderly | Placebo Comparator | Matching placebo for 10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching placebo | Drug | Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency [N (%)] of subjects with drug-related adverse events | days 1 to 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t) after administration of the last dose | 0 to 336 hours | |
| Cmax,ss (maximum measured concentration of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t) after administration of the last dose |
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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 |
|---|---|---|---|---|---|---|
| 1344.2.1 Boehringer Ingelheim Investigational Site | Berlin | Germany |
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| BI 1181181 healthy elderly | Drug | Tablet |
|
| BI 1181181 Healthy young | Drug | Tablet |
|
| 0 to 336 hours |
| 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) | 0 to 336 hours |
| Cmax (maximum measured concentration of the analyte in plasma) after administration of the first dose | 0 to 336 hours |
| AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t) after the administration of the last dose | 0 to 336 hours |
| AUCt,ss (area under the concentration-time curve of the analyte in CSF (if feasible) at steady state over a uniform dosing interval t after the administration of the last dose | 0 to 336 hours |