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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510318-25-00 | Registry Identifier | CTIS | |
| U1111-1304-0523 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3731579 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 3731579 dose group 1 | Experimental |
| |
| BI 3731579 dose group 2 | Experimental |
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| BI 3731579 dose group 3 | Experimental |
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| BI 3731579 dose group 4 | Experimental |
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| BI 3731579 dose group 5 | Experimental |
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| BI 3731579 dose group 6 | Experimental |
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| BI 3731579 dose group 7 | Experimental |
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| BI 3731579 dose group 8 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3731579 | Drug | BI 3731579 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) | up to 4 days | |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
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| Label | URL |
|---|---|
| Related Info | View source |
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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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 23, 2026 |
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|
| Placebo | Placebo Comparator |
|
| Matching placebo to BI 3731579 | Drug | Matching placebo to BI 3731579 |
|
| up to 4 days |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 4 days |