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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
34
Oral Tablet
Oral Tablet
BIOTRIAL
Rennes, France
Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
AUC0-t will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Cmax will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Area under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t)
AUC0-t will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞)
AUC0-∞ will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax)
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2)
t1/2 will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax)
Tmax will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
tlag will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz)
λz will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F)
Cl/F will be recorded from the PK blood samples collected.
Time frame: Day 1 up to Day 10
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vd/F)
Vd/F will be recorded from the PK blood samples collected
Time frame: Day 1 up to Day 10
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs)
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be decided by the investigator
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Vital Signs
Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Time frame: Baseline up to Day 21
Percentage of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings
Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
Time frame: Baseline up to Day 21
Percentage of Participants With Clinically Significant Changes in Physical Examination
Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Time frame: Baseline up to Day 21
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