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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
16
ODM-203 400mg as tablets taken 30 minutes after food
ODM-203 400mg as tablets taken 1 hour before a light breakfast
ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
Quotient Clinical Ltd
Nottingham, United Kingdom
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
Time frame: 0 to 72 hours
Number of adverse events
Number of adverse events counts
Time frame: 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
Time frame: 0 to 72 hours
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