Trials / Active Not Recruiting
Active Not RecruitingNCT03436485
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- Orion Corporation, Orion Pharma · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.
Detailed description
Safety and tolerability profile of ODM-208 will be explored
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ODM-208 | co-administered with glucocorticoid and fludrocortisone, orally daily |
| DRUG | Midazolam | orally |
Timeline
- Start date
- 2018-03-19
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
- First posted
- 2018-02-19
- Last updated
- 2025-07-22
Locations
20 sites across 4 countries: United States, Finland, France, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03436485. Inclusion in this directory is not an endorsement.