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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513590-45-00 | Registry Identifier | CTIS | |
| U1111-1307-2145 | Registry Identifier | WHO International Clinical Trials Registry Platform (ICTRP) |
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This trial aims to test how two different formulations of BI 690517 are taken up by the body and how probenecid influences the amount of BI 690517 in the blood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 690517 formulation 1, then BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2 | Experimental |
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| BI 690517 formulation 2, then Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1 | Experimental |
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| Probenecid + BI 690517 formulation 2, then BI 690517 formulation 1, then BI 690517 formulation 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 690517 formulation 1 | Drug | BI 690517 formulation 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point) | For the relative bioavailability of BI 690517. | Up to day 3. |
| Cmax (maximum measured concentration of BI 690517 in plasma) | For the relative bioavailability of BI 690517. | Up to day 3. |
| AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity) | For the drug interaction of BI 690517 with probenecid. | Up to day 3. |
| Cmax (maximum measured concentration of BI 690517 in plasma) | For the drug interaction of BI 690517 with probenecid. | Up to day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-∞ (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 extrapolated to infinity) | For the relative bioavailability of BI 690517. | Up to day 3. |
| AUC0-tz (area under the concentration-time curve of BI 690517 in plasma over the time interval from 0 to the last quantifiable data point) |
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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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| BI 690517 formulation 2 | Drug | BI 690517 formulation 2 |
|
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| Probenecid | Drug | Probenecid |
|
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For the drug interaction of BI 690517 with probenecid. |
| Up to day 3. |
| ID | Term |
|---|---|
| D011339 | Probenecid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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