Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

Key Inclusion Criteria: * Healthy males * Aged 50 to 65 years (inclusive) * Normal weight defined as a body mass index (BMI) of \>18.5 and \<32.0 kg/m2 * Weight 55 to 100 kg (inclusive) * Adequate method of contraception during the study and for a period of 6 months after study drug administration Key exclusion Criteria: * Evidence of clinically significant disease * Intake of any medication that could affect the outcome of the study * Known hypersensitivity to the active substances or the excipients of the drug or any serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients * History of anaphylactic/anaphylactoid reactions * Clinically significant abnormal biochemistry, haematology or urinalysis * Current or history of any drug or alcohol abuse in the past 2 years * Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) * Current use or use within the last 12 months of nicotine products * Positive drugs of abuse test result * Positive hepatitis B surface antigen, hepatitis C virus antibody or human immunodeficiency virus results * Presence or history of clinically significant allergy requiring treatment