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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510345-21-00 | Registry Identifier | CTIS | |
| U1111-1301-4856 | Registry Identifier | WHO - International Clinical Trials Registry Platform (ICTRP) |
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The purpose of this study is to find out how quickly and to what extent BI 3000202 is processed in the body.
The purpose of Part A is to find out how 3000202 moves through and exits the body of healthy people. The purpose of Part B is to find out how much BI 3000202 gets into the blood when participants take it as a tablet compared with when they get it as an infusion.
Adults between 18 and 55 years of age can take part if the study doctor determines they are healthy.
The doctors regularly check participants' health. To assess the study endpoints, the study staff takes blood, urine, and stool samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Absorption, distribution, metabolism, and excretion (ADME) |
|
| Part B | Experimental | Bioavailability (BA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 3000202 | Drug | BI 3000202 unlabelled |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: fe-urine, 0-tz (fraction excreted in urine as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) | up to 21 days | |
| Part A: fe-faeces, 0-tz (fraction excreted in faeces as percentage of the administered dose over the time interval from 0 to the last quantifiable time point) | up to 21 days | |
| Part B: AUC0-∞ (area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity) | up to 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Cmax (maximum measured concentration of the analyte) | up to 20 days | |
| Part A: AUC0-tz (area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point) | up to 20 days |
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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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| BI 3000202 [14C]-labelled |
| Drug |
BI 3000202 [14C]-labelled |
|
| Part B: Cmax | up to 6 days |
| Part B: AUC0-tz | up to 6 days |