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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002544-90 | EudraCT Number |
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The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Copanlisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copanlisib (BAY80-6946) | Drug | Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C] |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax) | Multiple time points up to 336 hours | |
| Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity (AUC) | Multiple time points up to 336 hours | |
| Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation (AUC(0-tlast)) | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in plasma by Cmax | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in plasma by AUC | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast) | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in whole blood by Cmax | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in whole blood by AUC | Multiple time points up to 336 hours | |
| Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast) | Multiple time points up to 336 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | Until 30 days after study drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C000589253 | copanlisib |
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| Radioactivity excreted in urine as a percentage of the dose (AE,ur) | Multiple time points up to 336 hours |
| Radioactivity excreted in feces as a percentage of the dose (AE,fec) | Multiple time points up to 336 hours |
| Metabolite profile in plasma | Multiple time points up to 336 hours |
| Metabolite profile in urine | Multiple time points up to 336 hours |
| Metabolite profile in feces | Multiple time points up to 336 hours |