Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments odm-201 tablet a, odm-201 tablet b, odm-201 capsule formulation
Phase phase 1
Sponsor Orion Corporation, Orion Pharma
Collaborator Endo Pharmaceuticals
Start date March 2013
End date August 2013
Trial size 30 participants
Trial identifier NCT01784757, 2012-002279-32, 3104003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
odm-201 tablet a
Tablet A formulation of ODM-201
odm-201 capsule formulation
Capsule formulation of ODM-201
(Experimental)
ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
odm-201 tablet b
Tablet B formulation of ODM-201
odm-201 capsule formulation
Capsule formulation of ODM-201

Primary Outcomes

Measure
Area under the curve (AUC) of ODM-201
time frame: 0-48 hrs
Cmax of ODM-201
time frame: 0-48 hrs

Secondary Outcomes

Measure
tmax of ODM-201
time frame: 0-48 hrs
Terminal elimination rate constant of ODM-201
time frame: 0-48 hrs
Terminal elimination half-life of ODM-201
time frame: 0-48 hrs

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

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
Principal investigator Karim Fizazi, MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Orion Corporation, Orion Pharma.