A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Tablet A formulation of ODM-201
Tablet B formulation of ODM-201
Capsule formulation of ODM-201
P. Stradina Clinical University Hospital
Riga, Latvia
Area under the curve (AUC) of ODM-201
The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
Time frame: 0-48 hrs
Cmax of ODM-201
The plasma peak concentration.
Time frame: 0-48 hrs
tmax of ODM-201
The time to reach peak concentration.
Time frame: 0-48 hrs
Terminal elimination rate constant of ODM-201
The terminal elimination rate constant from log-linear portion of a concentration-time curve.
Time frame: 0-48 hrs
Terminal elimination half-life of ODM-201
The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
Time frame: 0-48 hrs
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