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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002797-37 | EudraCT Number |
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The purpose of this trial is to investigate the fate of the roniciclib (study drug) in the body in a so called mass-balance study. This means to investigate how the study drug is absorbed, distributed, broken down (metabolized) and removed (excreted or eliminated) from the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Open label non-randomized non-controlled mass balance study in Cycle 1 |
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| Arm 2 | Experimental | Open label non-randomized non controlled multiple dose study in Cycle 2 and subsequent cycles |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| roniciclib (BAY 1000394) | Drug | Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Amount of Roniciclib in urine as percentage of the dose of total radioactivity. | Up to 336 hours | |
| Amount of Roniciclib in feces as percentage of the dose of total radioactivity. | Up to 336 hours | |
| Amount of Roniciclib in vomit as percentage of the dose of total radioactivity | Up to 336 hours | |
| Cmaxof roniciclib in plasma | up to 336 hours | |
| AUC(0-tlast) of roniciclib in plasma | up to 336 hours | |
| AUC of roniciclib in plasma | up to 336 hours | |
| Cmax of total radioactivity in whole blood and plasma | up to 336 hours | |
| AUC(0-tlast) of total radioactivity in whole blood and plasma | Up to 336 hours | |
| AUC of total radioactivity in whole blood and plasma | up to 336 hours |
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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 |
|---|---|---|---|---|---|---|
| PRA Magyarorszag Kft. Fazis I-es Klin.Farmakol. Vizsgalohely | Budapest | 1077 | Hungary |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C578610 | roniciclib |
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| roniciclib (BAY 1000394) | Drug | 5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days |
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