A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
- Written informed consent (IC) obtained.
- Histologically confirmed adenocarcinoma of prostate
- Progressive metastatic disease
- Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone
(LHRH) analogue or antagonist or bilateral orchiectomy
- Adequate bone marrow, hepatic and renal function
- Able to swallow the ODM-201 whole as a capsule or tablet.
- Previous chemotherapy for prostate cancer.
- Known metastases in the brain.
- History of other malignancy within the previous 5 years, except a basal cell
carcinoma of skin.
- Known gastrointestinal condition that can significantly affect the absorption of the
Type of Study:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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.
Outcome Time Frame:
Karim Fizazi, MD PhD
Institut Gustave Roussy, University of Paris
Finland: Finnish Medicines Agency
- Prostate Cancer
- Prostatic Neoplasms