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
Abstract
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.
Primary outcome: Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t); PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞); PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax).
Enrollment: 34 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 34 participants or records.
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