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

Part of paid clinical trials in Long Beach, California.

Sponsor
Ipsen
Study ID
NCT05543369
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 19, 2022
Status verified
Feb 2025
Primary completion
Mar 10, 2023
Completion
Mar 10, 2023

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1 : Healthy Japanese Participants
    Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.
  • Experimental: Cohort 2: Healthy Non-Asian Participants
    Participants will receive Elafibranor 80 mg once daily on Day 1 to Day 18.

Primary Outcome Measure

Noncompartmental Pharmacokinetics (PK) of Elafibranor and its Metabolite GFT1007: Area Under the Concentration-time Curve Over the Dosing Interval from Time 0 to 24 hours(AUCτ) [ Time Frame: Day 1 and Day 18 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Collaborative Neuroscience Research LLCLong BeachCalifornia90806-
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-

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