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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: ODM-203 (Period 1)
* Drug: ODM-203 (Period 2)
* Drug: ODM-203 (Periods 3-6)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Period 1<br>ODM-203 dosed after food | Drug: ODM-203 (Period 1)<br>* ODM-203 400mg as tablets taken 30 minutes after food<br>|
| Experimental: Period 2<br>ODM-203 dosed before food | Drug: ODM-203 (Period 2)<br>* ODM-203 400mg as tablets taken 1 hour before a light breakfast<br>|
| Experimental: Periods 3-6<br>ODM-203 dosed as a tablet or dispersion | Drug: ODM-203 (Periods 3-6)<br>* ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food | Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ODM-203 in the presence and absence of food | 0 to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events | Number of adverse events counts | From the date of informed consent to the date of the end of study estimated to be up to 17 weeks | 
| Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food | Area under the plasma concentration curve (AUC) will be measured to investigate the pharmacokinetic profile of ORM-21444 in the presence and absence of food | 0 to 72 hours |