Trials / Active Not Recruiting
Active Not RecruitingNCT03523442
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Subjects With Metastatic Castration-Resistant Prostate Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apalutamide | The participants will receive apalutamide 240 mg once daily orally. |
Timeline
- Start date
- 2018-08-31
- Primary completion
- 2019-07-09
- Completion
- 2026-12-31
- First posted
- 2018-05-14
- Last updated
- 2026-04-13
Locations
4 sites across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03523442. Inclusion in this directory is not an endorsement.