Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin

Sponsor
Genfit
Study ID
NCT03985969
Phase
PHASE1
Status
Completed

Conditions

  • Drug-drug Interaction

Eligibility Criteria

Sex
MALE
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • elafibranor — DRUG
    Elafibranor 120mg is a coated tablet for oral administration
  • CHRONO-INDOCID — DRUG
    CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration

Study Details

The enzyme responsible for the conversion of elafibranor into its active metabolite, GFT1007, has not been formally identified, but it is believed to have similar characteristics to an α,β-ketoalkene reductase previously identified in rat liver cytosol. In vitro studies in human liver cytosol fractions have shown that indomethacin inhibits the enzyme responsible of the transformation of elafibranor into GFT1007. As a result, indomethacin was included in the list of prohibited co-medications in all clinical trials with elafibranor, and a formal Drug-Drug Interaction (DDI) clinical study is being conducted to elucidate the effect of indomethacin on elafibranor pharmacokinetics.

Key Dates

Start date
Sep 23, 2019
Status verified
Aug 2020
Primary completion
Mar 15, 2020
Completion
Mar 31, 2020

Study Design

Enrollment
26 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: DDI
    Period 1: study of elafibranor's pharmacokinetics Period 2: study of elafibranor's pharmacokinetics under CHRONO-INDOCID® (indomethacin) at steady state

Primary Outcome Measure

Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞)) [ 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 (336 and 384 hours post-dose added in sequence 2) ]

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