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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522311-41-00 | Registry Identifier | CTIS | |
| U1111-1322-4722 | Registry Identifier | WHO Registry |
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The goal of this study is to find out how BI 1584862 moves through and exits the body of healthy men. To do this, BI 1584862 is labelled using radioactive carbon (C-14) and using a non-radioactive, naturally occurring, stable isotope (C-13). The study will measure how much of the study medicine is recovered in urine and faeces after taking it by mouth. It will also look at how much of the study medicine enters the bloodstream when taken by mouth compared to a small dose given directly into the bloodstream. The study staff measures the amount of BI 1584862 and its broken-down parts in the blood, the urine, and the stool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1584862 (C-14) (Test treatment) followed by [13C]-labeled BI 1584862 (Reference treatment) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [13C]-labeled BI 1584862 | Drug | [13C]-labeled BI 1584862, Reference treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz) | hADME part | Up to Day 14 |
| Fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz) | hADME part | Up to Day 14 |
| Sum of feurine,0-tz and fefaeces,0-tz (total recovery of [14C]-radioactivity) | hADME part | Up to Day 14 |
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) (AUC0-∞) | BA part | Up to day 13 |
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity in plasma) of [13C]-BI 1584862 after a single intravenous infusion of BI 1584862 (C-13) (AUC0-∞) | BA part | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (maximum measured concentration of the analyte in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) | hADME and BA part | Up to Day 13 |
| AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point in plasma) of BI 1584862 after a single oral administration of BI 1584862 (C-14) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON-Groningen-62040 | Groningen | 9728 NZ | Netherlands |
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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: https://www.mystudywindow.com/msw/datatransparency
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| Unlabeled BI 1584862 mixed with [14C]-labeled BI 1584862 | Drug | BI 1584862 (C-14), Test treatment |
|
hADME and BA part |
| Up to Day 13 |
| Cmax of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14) | hADME part | Up to Day 13 |
| AUC0-tz of [14C]-radioactivity after a single oral administration of BI 1584862 (C-14) | hADME part | Up to Day 13 |
| Cmax of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13) | BA part | Up to Day 6 |
| AUC0-tz of [13C]-BI 1584862 after a single intravenous administration of BI 1584862 (C-13) | BA part | Up to Day 6 |