Completed PHASE1 INTERVENTIONAL 4-arm NCT03765671

Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

An Open-label, Phase 1, Single-dose Study to Evaluate the Pharmacokinetics of Elafibranor 120 mg in Adult Subjects With Hepatic Impairment and Adult Healthy Control Subjects

Sponsor: Genfit

Conditions Hepatic Impairment Liver Disease Pharmacokinetics

Interventions Elafibranor

Updated 7 times since 2019 Last updated: Aug 21, 2019 Started: Dec 12, 2018 Primary completion: Jun 7, 2019 Completion: Jun 14, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03765671, this PHASE1 trial focuses on Hepatic Impairment and Liver Disease and remains completed. Sponsored by Genfit, it has been updated 7 times since 2018, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Sep 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Mar 2019 — Sep 2019 [monthly]

Recruiting PHASE1

▶ Show 2 earlier versions

Feb 2019 — Mar 2019 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Jan 2019 — Feb 2019 [monthly]

Not Yet Recruiting PHASE1

First recorded

Dec 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Genfit
Syneos Health
University of Miami

Data source: Genfit

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Miami, United States