Assessment of drug-drug interaction potential with EDP-305, a farnesoid X receptor agonist, in healthy subjects.

ABSTRACT: EDP-305 is a farnesoid X receptor (FXR) agonist that selectively activates FXR and is a potential treatment for patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis. Results from preclinical studies indicate that CYP3A4 is the primary enzyme involved in EDP-305 metabolism and that EDP-305 has low potential to inhibit or induce cytochrome (CYP) isoenzymes and drug transporters. Four studies were conducted in healthy volunteers to evaluate the drug-drug interaction (DDI) potential of EDP-305 co-administered with drugs known to be substrates for drug metabolizing enzymes or transporters, and to assess the effect of inhibitors and inducers of CYP3A4 on EDP-305. Results suggest caution when substrates of CYP3A4 are administered concomitantly with EDP-305. A potential for increa

SUBMITTER: Ahmad A 

PROVIDER: S-EPMC9468552 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature