Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: ODM-201 Tablet BDrug: ODM-201 Tablet ADrug: ODM-201 capsule formulation
- Registration Number
- NCT01784757
- Lead Sponsor
- Orion Corporation, Orion Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- 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 study treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ODM-201 Tablet B ODM-201 Tablet B ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order. ODM-201 Tablet A ODM-201 Tablet A ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. ODM-201 Tablet A ODM-201 capsule formulation ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. ODM-201 Tablet B ODM-201 capsule formulation ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
- Primary Outcome Measures
Name Time Method Cmax of ODM-201 0-48 hrs The plasma peak concentration.
Area under the curve (AUC) of ODM-201 0-48 hrs The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule.
- Secondary Outcome Measures
Name Time Method Terminal elimination rate constant of ODM-201 0-48 hrs The terminal elimination rate constant from log-linear portion of a concentration-time curve.
tmax of ODM-201 0-48 hrs The time to reach peak concentration.
Terminal elimination half-life of ODM-201 0-48 hrs The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant.
Trial Locations
- Locations (1)
P. Stradina Clinical University Hospital
🇱🇻Riga, Latvia