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

Phase 1
Completed
Conditions
Prostate Cancer
Interventions
Drug: ODM-201 Tablet B
Drug: ODM-201 Tablet A
Drug: 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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
ODM-201 Tablet BODM-201 Tablet BODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
ODM-201 Tablet AODM-201 Tablet AODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
ODM-201 Tablet AODM-201 capsule formulationODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
ODM-201 Tablet BODM-201 capsule formulationODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order.
Primary Outcome Measures
NameTimeMethod
Cmax of ODM-2010-48 hrs

The plasma peak concentration.

Area under the curve (AUC) of ODM-2010-48 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
NameTimeMethod
Terminal elimination rate constant of ODM-2010-48 hrs

The terminal elimination rate constant from log-linear portion of a concentration-time curve.

tmax of ODM-2010-48 hrs

The time to reach peak concentration.

Terminal elimination half-life of ODM-2010-48 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

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