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NCT01516047 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
A Phase 1 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01516047: Completed Phase 1 study, sponsored by Janssen Research & Development.
NCT01516047 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01516047, a Phase 1 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.
Interventions
- DRUG Cohort 2
- DRUG Cohort 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-09 |
| Phase | Phase 1 |
What the finished NCT01516047 record still lists
NCT01516047 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Cohort 2 is the first listed.
NCT01516047 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01516047 about?
NCT01516047 is a clinical study titled "A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function". The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult male patients with severe hepatic impairment and is being conducted to collect information that will support clinical dosing recommendations for this subpopulation.
What is the current status of trial NCT01516047?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-01. Estimated completion is 2012-09.
What interventions are being tested in trial NCT01516047?
The interventions under investigation include: Cohort 2 (DRUG), Cohort 1 (DRUG).
Who is sponsoring clinical trial NCT01516047?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01516047's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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