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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505683-11-00 | Registry Identifier | CTIS |
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The main objective of this trial is to investigate the absolute bioavailability of BI 1291583 (test treatment T, not radio-labelled) compared with BI 1291583 (C-14) (reference treatment R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1291583 alone (not radio-labelled, low dose) then [14C]-BI 1291583 (radio-labelled) | Experimental |
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| BI 1291583 alone (not radio-labelled, high dose) then [14C]-BI 1291583 (radio-labelled) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1291583 | Drug | BI 1291583 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured concentration of the analyte in plasma (Cmax) | Up to 10 days | |
| Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point (AUC0-tz) | Up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON | 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:
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| [14C]-BI 1291583 | Drug | [14C]-BI 1291583 |
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