clinical trial · NCT05543369
Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants
Ipsen·phase1·completed·n = 48
Healthy VolunteersElafibranor
brief summary
This study is intended to measure the blood levels of Elafibranor and one of its metabolites in Japanese and non-Asian Healthy Participants, to be able to compare how the body absorbs, distributes, and eliminates Elafibranor after Repeat Administration, in order to support inclusion of Japanese patients in the planned clinical studies with elafibranor.
started
Sep 19, 2022
primary completion
Mar 10, 2023
completion
Mar 10, 2023
last updated
Feb 20, 2025
official title
A Phase I, Single-Centre, Open-Label, Repeat Dose Study to Assess the Pharmacokinetics, Safety and Tolerability Following Administration of Elafibranor in Healthy Japanese and Non-Asian Participants.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol