A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Cmax of ODM-201
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ODM-201 Tablet A
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Intervention: ODM-201 Tablet A (Drug)
ODM-201 Tablet A
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Intervention: ODM-201 capsule formulation (Drug)
ODM-201 Tablet B
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Intervention: ODM-201 Tablet B (Drug)
ODM-201 Tablet B
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Intervention: ODM-201 capsule formulation (Drug)
Outcomes
Primary Outcomes
Cmax of ODM-201
Time Frame: 0-48 hrs
The plasma peak concentration.
Area under the curve (AUC) of ODM-201
Time Frame: 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 Outcomes
- Terminal elimination rate constant of ODM-201(0-48 hrs)
- tmax of ODM-201(0-48 hrs)
- Terminal elimination half-life of ODM-201(0-48 hrs)