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

NCT01784757 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ODM-201 Tablet A

Tablet A formulation of ODM-201

DRUG

ODM-201 Tablet B

Tablet B formulation of ODM-201

DRUG

ODM-201 capsule formulation

Capsule formulation of ODM-201

Sponsors & Collaborators

  • Endo Pharmaceuticals

    collaborator INDUSTRY

  • Orion Corporation, Orion Pharma

    lead INDUSTRY

Principal Investigators

  • Karim Fizazi, MD PhD · Institut Gustave Roussy, University of Paris

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-08-31
Completion
2020-12-31

Countries

  • Latvia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01784757 on ClinicalTrials.gov