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Clinical Trials/NCT01784757
NCT01784757CompletedPhase 1

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

Orion Corporation, Orion Pharma1 site in 1 country30 target enrollmentStarted: March 2013Last updated:
Conditions
Interventions
Drugs

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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