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This is an open label, single dose, 1 period study of [14C] galeterone.
This is an open label, 1 period study under fed conditions. Six (6), healthy, adult, non tobacco using, male subjects will be enrolled. Screening of subjects will occur within 28 days prior to dosing. On Day 1, a single dose of radio-labeled galeterone will be administered orally. Blood, urine, and fecal samples will be collected until release criteria are met to measure total radioactivity, for analysis of galeterone concentrations, and for potential metabolic profiling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of [14C]-galeterone | Experimental | [14C]-galeterone will be supplied as 325 mg capsules (powder in capsule [PIC]). The treatment to be administered will be 2600 mg (~500 µCi) (8 x 325 mg capsules). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| galeterone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity concentration equivalents in plasma | 168 hours | |
| Single dose galeterone concentrations in plasma | 168 hours | |
| Route(s) of elimination of a single [14C]galeterone dose | 8 days | |
| Mass balance of a single [14C]galeterone dose | 8 days | |
| Ratio of whole blood to plasma 14C radioactivity | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen J Ferrante, MD | Tokai Pharmaceuticals, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C500627 | 3-hydroxy-17-(1H-benzimidazole-1-yl)androsta-5,16-diene |
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