Healthy
Conditions
Brief summary
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
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.
Interventions
DRUGODM-203 (Period 1)
ODM-203 400mg as tablets taken 30 minutes after food
DRUGODM-203 (Period 2)
ODM-203 400mg as tablets taken 1 hour before a light breakfast
DRUGODM-203 (Periods 3-6)
ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
Sponsors
Quotient Clinical
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration curve(AUC) ODM-203 in the presence and absence of food | 0 to 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | From the date of informed consent to the date of the end of study estimated to be up to 17 weeks | Number of adverse events counts |
| Area under the plasma concentration curve(AUC) ORM-21444 in the presence and absence of food | 0 to 72 hours | 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 |
Countries
United Kingdom
Outcome results
None listed