Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: ODM-201 Tablet A
* Drug: ODM-201 Tablet B
* Drug: ODM-201 capsule formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ODM-201 Tablet A<br>ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. | Drug: ODM-201 Tablet A<br>* Tablet A formulation of ODM-201<br>Drug: ODM-201 capsule formulation<br>* Capsule formulation of ODM-201<br>|
| Experimental: ODM-201 Tablet B<br>ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order. | Drug: ODM-201 Tablet B<br>* Tablet B formulation of ODM-201<br>Drug: ODM-201 capsule formulation<br>* Capsule formulation of ODM-201<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0-48 hrs | 
| Cmax of ODM-201 | The plasma peak concentration. | 0-48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tmax of ODM-201 | The time to reach peak concentration. | 0-48 hrs | 
| Terminal elimination rate constant of ODM-201 | The terminal elimination rate constant from log-linear portion of a concentration-time curve. | 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. | 0-48 hrs |