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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002279-32 | EudraCT Number |
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| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODM-201 Tablet A | Experimental | ODM-201 tablet A in fed and fasted states plus ODM-201 capsule in fed state in randomised order. |
|
| ODM-201 Tablet B | Experimental | ODM-201 Tablet B in fed and fasted states plus ODM-201 capsule in fed state in randomised order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODM-201 Tablet A | Drug | Tablet A formulation of ODM-201 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of ODM-201 | The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration calculated with linear trapezoidal rule. | 0-48 hrs |
| Cmax of ODM-201 | The plasma peak concentration. | 0-48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| tmax of ODM-201 | The time to reach peak concentration. | 0-48 hrs |
| Terminal elimination rate constant of ODM-201 | The terminal elimination rate constant from log-linear portion of a concentration-time curve. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karim Fizazi, MD PhD | Institut Gustave Roussy, University of Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P. Stradina Clinical University Hospital | Riga | Latvia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28753851 | Derived | Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000607739 | darolutamide |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| ODM-201 Tablet B |
| Drug |
Tablet B formulation of ODM-201 |
|
| ODM-201 capsule formulation | Drug | Capsule formulation of ODM-201 |
|
| 0-48 hrs |
| Terminal elimination half-life of ODM-201 | The terminal elimination half-life that will be calculated with the equation ln2/terminal elimination rate constant. | 0-48 hrs |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |