Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Hepatic Impairment and Pharmacokinetics, sponsored by Genfit.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
In participants with mild, moderate and severe hepatic impairment compared to healthy volunteers
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 |
What the finished NCT03765671 record still lists
NCT03765671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 36-participant average among 48 other Hepatic Impairment trials with a reported enrollment target (17% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatic Impairment
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03765671's enrollment target sits among peer trials
30 21st of 48 higher than 24 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
RECRUITING · Phase 1
-
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
RECRUITING · Phase 1
-
A Study to Learn How the Body Processes the Study Medicine PF-07328948 in People With and Without Reduced Liver Function
RECRUITING · Phase 1
-
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
RECRUITING · Phase 1
-
Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease
RECRUITING · Phase 1
-
A Study of Calderasib (MK-1084) in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI