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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002502-49 | EudraCT Number |
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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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A study to evaluate the bioavailability (BA) of a single oral dose of MDV3100 (enzalutamide) formulated as a solid spray dried tablet compared to oral liquid-filled capsules, and the safety and tolerability of oral formulations.
Subjects are admitted to the clinic from days 1 to 5, followed by outpatient assessments up to Day 50. They return to the clinic for an end of study visit (ESV) 7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Single dose of 4 liquid-filled capsules of MDV3100 reference formulation |
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| Treatment B | Experimental | Single dose of 2 tablets of MDV3100 formulation tablet B |
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| Treatment C | Experimental | Single dose of 2 tablets of MDV3100 formulation tablet C |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MDV3100 | Drug | Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions | AUC0-t (Area Under Curve from time zero to last quantifiable sample), AUC0-inf (AUC extrapolated to infinity), Cmax (Maximum concentration) | Day 1 through Day 50 (26 times) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative BA of capsule and tablet formulations of enzalutamide following a single dose of enzalutamide under fasted conditions | AUC0-72h (AUC from time zero to 72h post dose), AUC0-t, AUC0-inf, %AUC (Percentage of AUC), Cmax, tmax (Time to attain Cmax), λz (Terminal elimination rate constant), t1/2 (Terminal elimination half life), (MPR) metabolites to parent ratio, MPR(molecular weight corrected [MWC]), %AUC, CL/F (apparent oral clearance), Vz/F (apparent volume of distribution) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Manager | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | 14050 | Germany |
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| Day 1 through Day 50 (26 times) |
| Safety and tolerability of oral formulations of enzalutamide | adverse events, physical examination, vital signs, clinical laboratory tests, 12-lead Electrocardiogram (ECG) | Screening through ESV (7-10 days after the last pharmacokinetic (PK) sampling or after early withdrawal) |
| ID | Term |
|---|---|
| C540278 | enzalutamide |
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