MedTrace Logo

Study to Compare the Level of Elafibranor in Blood After Repeat Administration in Japanese and Non-Asian Healthy Participants

NCT05543369 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-02-20

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Elafibranor

Oral Tablet

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2023-03-10
Completion
2023-03-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543369 on ClinicalTrials.gov