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

NCT03985969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Drug-drug Interaction

Interventions

DRUG

elafibranor

Elafibranor 120mg is a coated tablet for oral administration

DRUG

CHRONO-INDOCID

CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pascal Birman, MD · Genfit

Study Design

Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2020-03-15
Completion
2020-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985969 on ClinicalTrials.gov