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

A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects

A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

6 healthy male subjects will be enrolled in part 1 and part 2 of the study, respectively

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