Elafibranor Pharmacokinetic Parameters in Renal Impaired Patients

Sponsor
Genfit
Study ID
NCT03844555
Phase
PHASE1
Status
Completed

Conditions

  • Kidney Diseases
  • Pharmacokinetics
  • Renal Impairment
  • Renal Insufficiency

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 participants with renal impairment. Pharmacokinetic parameters of elafibranor and its active metabolite (GFT1007) will be compared in severe renal impaired participants (eGFR\<15mL/mn/1.73m\^2) versus healthy participants after a single oral administration of elafibranor 120 mg

Key Dates

Start date
Feb 28, 2019
Status verified
Aug 2020
Primary completion
Mar 15, 2020
Completion
Mar 21, 2020

Study Design

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

Arms

  • Experimental: End Stage Renal Disease
    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 ]

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