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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: Completed Phase 1 study of Hepatic Impairment, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C (last)/ lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to the time of the last measurable concentration, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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 |
What the finished NCT04154774 record still lists
NCT04154774 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (50% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
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Where NCT04154774's enrollment target sits among peer trials
18 42nd of 48 higher than 5 of 48 other Hepatic Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Impairment 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.
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