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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000089-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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A study to investigate the excretion routes of radio-labelled MDV3100.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Oral MDV3100 dose | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDV3100 | Drug | Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Maximum concentration (Cmax) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Time to attain Cmax (tmax) | Time to attain Cmax (tmax) | Day 1 through Day 78 (21 times) |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Time to reach quantifiable concentrations (tlag) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by AUC from the time of dosing to the last measurable concentration (AUC0-t) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by AUC extrapolated to infinity (AUC0-inf) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Terminal Disposition Rate Constant (λz) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent terminal elimination half life (t1/2) | Day 1 through Day 78 (21 times) | |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent total body clearance after extra vascular dosing (CL/F) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) | Day 1 through Day 78 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Operation Senior Research Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Zuidlaren | 9471GP | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25917876 | Derived | Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5. |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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| Day 1 through Day 78 (21 times) |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by Apparent volume of distribution during the terminal phase after extra vascular dosing (Vz/F) | Day 1 through Day 78 (21 times) |
| Assessment of Pharmacokinetic profile of total radioactivity in plasma and whole blood by blood-to-plasma ratio (Ratio Cb/p) | Day 1 through Day 78 (21 times) |
| Assessment of 14C recovery in urine | Day 1 through Day 78 (17 times) |
| Assessment of 14C recovery in feces | Day 1 through Day 78 (16 times) |
| Assessment of total 14C recovery (urine and feces combined) within 24 hours | Day 1 through Day 78 (17 times for urine and 16 times for feces) |
| Assessment of total 14C recovery (urine and feces combined) after Time of last quantifiable concentration (tlast) | Day 1 through Day 78 (17 times for urine and 16 times for feces) |
| Assessment of Pharmacokinetic profile of MDV3100 and metabolites in plasma | PK of MDV3100, MDPC0001, and MDPC0002 in plasma based on validated LC-MS/MS methods:
The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated | Day 1 through Day 78 (21 times) |
| Assessment of Pharmacokinetic profile of MDV3100 and metabolites in urine | PK of MDV3100, MDPC0001, and MDPC0002 in urine based on validated LC-MS/MS methods:
The ratios of AUCMDV3100/AUC14C , AUCMDPC0001/AUCMDV3100 and AUCMDPC0001/AUC14C (and the same for MDPC0002) will be calculated | Day 1 through Day 78 (17 times) |
| Metabolic Profile: Profiling of possible metabolites of MDV3100 in plasma, urine, and feces | Identification and possible quantification of metabolites in plasma, and if applicable, in urine and feces | Day 1 through Day 78 (14 times) |