Trials / Completed
CompletedNCT02363855
Phase 1 Dose Escalation Study of BAY 1841788 in Japanese Metastatic Castration-resistant Prostate Cancer (mCRPC) Subjects
An Open Label Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BAY 1841788 in Japanese Subjects With Metastatic Castration-resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to investigate the safety and tolerability of BAY 1841788 in Japanese subjects with metastatic castration-resistant prostate cancer (mCRPC) and the PK of BAY 1841788 and its major metabolite BAY 1896953.
Detailed description
The drug product is licensed from Orion pharma, Finland which is also the manufacturer of the product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY 1841788(ODM-201) | Cohort 1: Single dose 300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks Cohort 2: Single dose 2x300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks. |
Timeline
- Start date
- 2015-02-23
- Primary completion
- 2015-11-19
- Completion
- 2018-01-18
- First posted
- 2015-02-16
- Last updated
- 2018-01-25
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT02363855. Inclusion in this directory is not an endorsement.