Phase 1Completed
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
- Sponsor
- Genfit (Industry)
- Enrollment
- 26 enrolled
- Conditions
- Drug-drug Interaction
- Interventions
- elafibranor; CHRONO-INDOCID
- Ages
- adults
- Registry
- NCT03985969, EUCTR2019-001451-38
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Plasma pharmacokinetics: Area under curve from dosing time to infinity (AUC(0-∞))
- Plasma pharmacokinetics: Maximum plasma drug concentration (Cmax)
History
Last registry update
Study completion
Primary completion
Started
Registered