Elafibranor Pharmacokinetic Parameters in Hepatic Impaired Patients

Part of paid clinical trials in Miami, Florida.

Sponsor
Genfit
Study ID
NCT03765671
Phase
PHASE1
Status
Completed

Conditions

  • Hepatic Impairment
  • Liver Disease
  • Pharmacokinetics

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 12, 2018
Status verified
Aug 2019
Primary completion
Jun 7, 2019
Completion
Jun 14, 2019

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Mild Child-Pugh A
    Single oral dose of elafibranor 120mg
  • Experimental: Moderate Child-Pugh B
    Single oral dose of elafibranor 120mg
  • Experimental: Severe Child-Pugh C
    Single oral dose of elafibranor 120mg
  • Experimental: Healthy
    Single oral dose of elafibranor 120mg

Primary Outcome Measure

Area under curve from dosing time to last measurement (AUC(0-t)) of elafibranor and active metabolite [ Time Frame: pre-dose and at 0.17, 0.33, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192 and 216 hours post-dose. Additionally, after elafibranor administration at 288 and 384 hours for hepatic impaired patients ]

Locations (2)

FacilityCityStateZIPSite coordinators
Division of Clinical Pharmacology, University of MiamiMiamiFlorida33136-
inVentiv Health Clinical ResearchMiamiFlorida33136-

Find similar trials in Miami, FL

By research site
Division of Clinical Pharmacology, University of Miami· Miami, FLinVentiv Health Clinical Research· Miami, FL

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