NCT05564208

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

A Phase I, Open-Label, Randomised, Balanced, Single-Dose, Two-Period, Two-Sequence Crossover-Design Study to Evaluate Effects of Food on the Bioavailability of 80 mg Elafibranor (IPN60190) To-be-marketed Tablet Formulation After Single Oral Administration in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	elafibranor	Oral Tablet
DRUG	elafibranor	Oral Tablet

Timeline

• Start date: 2022-10-27
• Primary completion: 2022-12-30
• Completion: 2023-01-14
• First posted: 2022-10-03
• Last updated: 2025-02-20

Locations

1 site across 1 country: France