14C-ARN-509 Microtracer Label AME and Absolute BA Study

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.

Key Inclusion Criteria:

• Gender : male
• Age : 50 - 80 years, inclusive
• Body Mass Index (BMI) : 18.5-30.0 kg/m2
• Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), grapefruit (juice) and tobacco products from 48 h prior to entry in the clinical research center until discharge
• Medical history without major pathology

Key Exclusion Criteria:

• Evidence of clinically relevant pathology.
• Mental handicap.
• History of relevant drug and/or food allergies.
• Regular/routine treatment with non-topical medications within 30 days prior to entry into the clinical research center.
• Smoking.
• History of alcohol abuse or drug addiction (including soft drugs like cannabis products).
• Use of concomitant medication, except for acetaminophen (paracetamol) and topical medications
• Irregular defecation pattern (less than once per 2 days).
• Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, and alcohol).
• Intake of more than 24 units of alcohol per week (one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits).
• Positive screen on HBsAg, anti-HCV or anti-HIV 1/2.
• Illness within five days prior to drug administration.