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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004563-32 | EudraCT Number | EudraCT |
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To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 BI 1181181 low dose | Experimental | tablet |
|
| BI 1181181 high dose | Experimental | tablet |
|
| Placebo | Experimental | tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1181181 high dose | Drug | two tablet |
| |
| BI 1181181 low dose |
| Measure | Description | Time Frame |
|---|---|---|
| %-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM) | up to 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid 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 and cerebrospinal fluid) |
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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 |
|---|---|---|---|---|---|---|
| 1344.20.32001 Boehringer Ingelheim Investigational Site | Antwerp | Belgium |
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| Drug |
one tablet |
|
| Placebo | Drug | tablet |
|
| up to 72 h |
| AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity) | up to 72 h |