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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 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 16 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01516047
The ClinicalTrials.gov registry entry for NCT01516047 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cohort 2 is the first listed.
NCT01516047 reports 0 study locations.
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.
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