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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001818-18 | EudraCT Number |
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The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: BI 690517 (C-14) | Experimental |
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| Part B: BI 690517 fasted (test treatment, T) / BI 690517 (C-14) (reference treatment, R) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 690517 (C-14) | Drug | BI 690517 (C-14) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Fraction of [14C] radioactivity excreted into urine given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe urine,0-tz ) | Up to 22 days. | |
| Part A: Fraction of [14C] radioactivity excreted into feces given as percentage of the administered dose in the time interval from 0 to last quantifiable time point (fe feces, 0-tz) | Up to 22 days. | |
| Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after intravenous administration (AUC0-∞) | Up to 3 days. | |
| Part B: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration (AUC0-∞) | Up to 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: 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 8 days. | |
| Part A: Maximum measured concentration of the analyte in plasma (Cmax) | Up to 8 days. |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will not be allowed to participate, if any of the following general criteria apply:
Further exclusion criteria apply.
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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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| ID | Term |
|---|---|
| C000615234 | Carbon-14 |
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| BI 690517 | Drug | BI 690517 |
|
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| Part B: Maximum measured concentration of the analyte in plasma (Cmax) | Up to 3 days. |
| Part B: 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 3 days. |