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NCT05674474 · ClinicalTrials.gov registry record · Phase 1
A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function
A Phase 1 study of Hepatic Impairment, sponsored by Institut de Recherches Internationales Servier.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT05674474 is a Phase 1 study of Hepatic Impairment that has completed, run by Institut de Recherches Internationales Servier. The registered enrollment target is 16 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05674474, a Phase 1 study of Hepatic Impairment, has completed, sponsored by Institut de Recherches Internationales Servier.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
Conditions Studied
Interventions
- DRUG Vorasidenib
Study Locations (1)
Texas
- American Research Corporation - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-03-14 |
| Est. Completion | 2023-07-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674474
The ClinicalTrials.gov registry entry for NCT05674474 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, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (56% lower). The listed sponsor is Institut de Recherches Internationales Servier, which has 27 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 Vorasidenib is the first listed.
NCT05674474 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05674474 about?
NCT05674474 is a clinical study titled "A Study of Vorasidenib in Participants With Moderate or Mild Hepatic Impairment and Matched Participants With Normal Hepatic Function". The primary purpose of this study is to estimate the effect of moderate or mild hepatic impairment on the pharmacokinetic (PK) profile of a single oral dose of 20 mg vorasidenib in participants with hepatic impairment relative to healthy matched control participants with normal hepatic function.
What is the current status of trial NCT05674474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2023-03-14. Estimated completion is 2023-07-18.
What conditions does trial NCT05674474 study?
This clinical trial studies the following conditions: Hepatic Impairment.
What interventions are being tested in trial NCT05674474?
The interventions under investigation include: Vorasidenib (DRUG).
Who is sponsoring clinical trial NCT05674474?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05674474 being conducted?
This trial has 1 study location across Texas. 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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