Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001727-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 765250.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 765250 arm | Experimental |
| |
| Placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 765250 | Drug | BI 765250 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with treatment-emergent adverse events assessed as drug-related by the investigator | Up to 172 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 169 days | |
| Maximum measured concentration of the analyte in serum (Cmax) | Up to 169 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Science Services - Clinical Research | Edegem | 2650 | Belgium |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Placebo |
|