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NCT04154774 · ClinicalTrials.gov registry record · Phase 1
A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function
A Phase 1 study of Hepatic Impairment, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT04154774 is a Phase 1 study of Hepatic Impairment that has completed, run by Janssen Research & Development. The registered enrollment target is 18 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT04154774, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
Conditions Studied
Interventions
- DRUG Apalutamide
Study Locations (4)
Florida
- Homestead Associates in Research Inc - Homestead
- Orlando Clinical Research Center - Orlando
- Genesis Clinical Research - Tampa
Tennessee
- VGR & NOCCR - Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-11-07 |
| Est. Completion | 2025-02-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04154774
The ClinicalTrials.gov registry entry for NCT04154774 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Apalutamide is the first listed.
NCT04154774 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04154774 about?
NCT04154774 is a clinical study titled "A Study of Apalutamide in Participants With Severe Hepatic Impairment Compared With Participants With Normal Hepatic Function". The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of apalutamide in participants with severe hepatic impairment relative to participants with normal hepatic function.
What is the current status of trial NCT04154774?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-11-07. Estimated completion is 2025-02-10.
What conditions does trial NCT04154774 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT04154774?
The interventions under investigation include: Apalutamide (DRUG).
Who is sponsoring clinical trial NCT04154774?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04154774 being conducted?
This trial has 4 study locations across Florida, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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