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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Single oral dose of 240 mg ARN-509
PRA - Clinical Research Unit, University Medical Centre Groningen
Groningen, Netherlands
Mass Balance
To determine the rate and routes of excretion of ARN-509 in urine, feces, and expired air
Time frame: 2 months 10 days
Absolute Oral Bioavailability
To determine absolute oral bioavailability of ARN-509
Time frame: 2 months 10 days
Metabolite Profile
To identify and quantify the ARN-509 metabolites in plasma, urine, and feces
Time frame: 2 months 10 days
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