Trials / Completed
CompletedNCT01784757
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
A Bioavailability Study of ODM-201 Formulations With a Safety and Tolerability Extension Component in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2013-08-01
- Completion
- 2020-12-01
- First posted
- 2013-02-06
- Last updated
- 2021-03-17
Locations
1 site across 1 country: Latvia
Source: ClinicalTrials.gov record NCT01784757. Inclusion in this directory is not an endorsement.