NCT03985969

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

Phase 1, Open-label Study, in Healthy Male Volunteers to Evaluate the Potential Effect of Indomethacin on the Pharmacokinetics Parameters of Elafibranor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Genfit · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-09-23
• Primary completion: 2020-03-15
• Completion: 2020-03-31
• First posted: 2019-06-14
• Last updated: 2020-08-13

Locations

1 site across 1 country: France