Study to Investigate the Potential Drug-Drug Interaction Between Elafibranor and Indomethacin
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
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.