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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004899-19 | EudraCT Number |
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This is study in healthy human volunteers to determine the absorption, metabolism, and excretion (AME) profile of ARN-509 as well as its absolute oral bioavailability (BA).
Two cohorts of 6 healthy volunteers will be enrolled for the AME and absolute BA parts, respectively. The dose for both cohorts is 240 mg. The expected exposure of the dose is 7-fold lower than the steady state reached in patients with castration-resistant prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - 14C labeled ARN-509 | Active Comparator | Single oral dose of 240 mg ARN-509, followed after 2 hours (at the average tmax of ARN-509) by an intravenous (i.v.) microdose of 100 μg (9.25 kBq, 250 nCi) 14C-ARN-509 |
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| Part B: 14C labeled ARN-509 | Active Comparator | Single oral dose of 240 mg ARN-509, followed after 2 hours (at the average tmax of ARN-509) by an oral dose of 240 mg ARN-509 with 37 kBq (1000 nCi) of 14C-ARN-509 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARN-509 | Drug | Single oral dose of 240 mg ARN-509 |
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| Measure | Description | Time Frame |
|---|---|---|
| Mass Balance | To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air | 2 months 10 days |
| Absolute Oral Bioavailability | To determine absolute oral bioavailability of ARN-509 | 2 months 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite Profile | To identify and quantify the ARN-509 metabolites in plasma, urine, and feces | 2 months 10 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada al Kotbi, MD | PRA International Group BV | Principal Investigator |
| Helen Pruim-Tait, MA, MSc | PRA International Group BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA - Clinical Research Unit, University Medical Centre Groningen | Groningen | Netherlands |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
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