Impact of Changing the Dosing Regimen on the PK Profile of ODM-203

A Part-randomised, Single Centre, Single Dose, Crossover,Phase I Study to Investigate the Impact of Changes to the Dosing Regimen on the Pharmacokinetic Profile of ODM-203 in Healthy Male Volunteers

This Phase I study in healthy male volunteers will evaluate the impact of the effect of food on the pharmacokinetic profile of ODM-203.

This study will be a single dose part randomised cross over study with up to 6 study periods. ODM-203 may be dosed using a variety of different conditions with respect to food depending on emerging data. The impact of changing the presentation of ODM-203 may also be assessed to determine the PK of alternative formulations and identify appropriate drug formulations for further development.

Inclusion Criteria:

• Written informed consent
• Able to speak, write and understand English
• Body mass index of 18.0-32.0
• Weight 55-95 kg
• Adequate method of contraception
• Good state of health

Exclusion Criteria:

• Receipt of IMP in a clinical research study or donation/loss of >400ml blood within previous 3 months or previously enrolled in this study
• History of drug or alcohol abuse or positive drugs of abuse test or regular alcohol consumption or current smoker/user of nicotine replacement products
• Positive drugs of abuse test
• Positive hepatitis B, hepatitis C or HIV results
• Donation/loss of >400ml blood within previous 3 months
• Poor compliance or inability to follow protocol requirements/instructions/restrictions.
• Vulnerable subjects
• Evidence of clinically relevant disease of any body system including relevant psychiatric disorders or conditions requiring regular concomitant medication
• History of significant hypersensitivity, anaphylaxis, intolerance to drugs/food
• Propensity to get headaches when refraining from caffeine containing beverages
• Any abnormal laboratory value, vital signs, ECG parameter or physical examination interfering with the test results or causing a health risk for the subject or failure to satisfy the investigator of fitness to participate for any other reason.