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NCT03765671 · ClinicalTrials.gov registry record · Phase 1
Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients
A Phase 1 study of Hepatic Impairment and Pharmacokinetics, sponsored by Genfit.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT03765671 is a Phase 1 study of Hepatic Impairment and Pharmacokinetics that has completed, run by Genfit. The registered enrollment target is 30 participants, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (17% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03765671, a Phase 1 study of Hepatic Impairment and Pharmacokinetics, has completed, sponsored by Genfit.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child-Pugh categories) versus healthy participants after a single oral administration of elafibranor 120 mg.
Conditions Studied
Interventions
- DRUG Elafibranor
Study Locations (2)
Florida
- Division of Clinical Pharmacology, University of Miami - Miami
- inVentiv Health Clinical Research - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-12-12 |
| Est. Completion | 2019-06-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03765671
The ClinicalTrials.gov registry entry for NCT03765671 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 (17% lower). The listed sponsor is Genfit, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Hepatic Impairment appearing as the primary indexed condition, and to 1 intervention - of which Elafibranor is the first listed.
NCT03765671 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT03765671 about?
NCT03765671 is a clinical study titled "Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients". This study is being conducted in order to assess the need for dose adjustment for elafibranor in patients with hepatic impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in hepatic impaired patients (mild, moderate and severe according to Child...
What is the current status of trial NCT03765671?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-12-12. Estimated completion is 2019-06-14.
What conditions does trial NCT03765671 study?
This clinical trial studies the following conditions: Hepatic Impairment, Pharmacokinetics, Liver Disease.
What interventions are being tested in trial NCT03765671?
The interventions under investigation include: Elafibranor (DRUG).
Who is sponsoring clinical trial NCT03765671?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03765671 being conducted?
This trial has 2 study locations across Florida. 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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