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The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole | Drug | Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole. | 1 month | |
| Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. | 1 month | |
| Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole. | 1 month |
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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 |
|---|---|---|---|---|---|---|
| Brighton | Massachusetts | 02135 | United States |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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| Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole. | 1 month |