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A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet

NCT05564208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-02-20

No results posted yet for this study

Summary

This study will evaluate the effects of food on how much test drug is able to access the circulation and reach the target area (known as bioavailability).

The test drug, elafibranor (IPN60190), is in development for the treatment of primary biliary cholangitis (PBC).

PBC is a rare, long-term autoimmune disease of the liver. An autoimmune disease occurs when the immune (defence) system treats healthy parts of the body as if they were foreign and attacks them.

This study will be in healthy volunteers, so this trial is not to test if the drug helps to improve health.

Conditions

  • Healthy Participants

Interventions

DRUG

elafibranor

Oral Tablet

DRUG

elafibranor

Oral Tablet

Sponsors & Collaborators

Principal Investigators

  • Ipse Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2022-12-30
Completion
2023-01-14

Countries

  • France

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 NCT05564208 on ClinicalTrials.gov