A Study to Evaluate the Effect of Food on the Level of Circulating Elafibranor in Healthy Participants After Intake of a Single Tablet
- Registration Number
- NCT05564208
- Lead Sponsor
- Ipsen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Elafibranor Fasting then Elafibranor fed elafibranor Participants will receive Elafibranor 80 mg in Fasting State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fed State on Day 1 of Period 2. Elafibranor Fed then Elafibranor fasting elafibranor Participants will receive Elafibranor 80 mg in Fed State on Day 1 of Period 1 followed by a washout period of a maximum of 28 days. Participants will then receive Elafibranor 80 mg in Fasting State on Day 1 of Period 2.
- Primary Outcome Measures
Name Time Method Pharmacokinetics (PK) of Elafibranor: Area Under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t) Day 1 up to Day 10 AUC0-t will be recorded from the PK blood samples collected.
PK of Elafibranor: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞) Day 1 up to Day 10 AUC0-∞ will be recorded from the PK blood samples collected.
PK of Elafibranor: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Day 1 up to Day 10 Cmax will be recorded from the PK blood samples collected.
- Secondary Outcome Measures
Name Time Method PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Half-life (t1/2) Day 1 up to Day 10 t1/2 will be recorded from the PK blood samples collected.
PK of Elafibranor and its Metabolite GFT1007: Time to Maximum Observed Drug Concentration (Tmax) Day 1 up to Day 10 Tmax will be recorded from the PK blood samples collected.
Percentage of Participants With Treatment Emergent Adverse Event (TEAEs) and Adverse Events of Special Interest (AESIs) Baseline up to Day 21 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
PK of Elafibranor's Metabolite GFT1007: Area under the Plasma Concentration Time Curve From Zero to the Last Quantifiable Concentration (AUC0-t) Day 1 up to Day 10 AUC0-t will be recorded from the PK blood samples collected.
PK of Elafibranor's Metabolite GFT1007: Area Under Plasma Concentration Time Curve From Zero to Infinity (AUC0-∞) Day 1 up to Day 10 AUC0-∞ will be recorded from the PK blood samples collected.
PK of Elafibranor's Metabolite GFT1007: Maximum Observed Plasma (peak) Drug Concentration (Cmax) Day 1 up to Day 10 PK of Elafibranor and its Metabolite GFT1007: Terminal Elimination Rate Constant (λz) Day 1 up to Day 10 λz will be recorded from the PK blood samples collected.
PK of Elafibranor and its Metabolite GFT1007: Total Body Clearance (Cl/F) Day 1 up to Day 10 Cl/F will be recorded from the PK blood samples collected.
Percentage of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings Baseline up to Day 21 Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be decided by the investigator.
PK of Elafibranor and its Metabolite GFT1007: Volume of distribution (Vd/F) Day 1 up to Day 10 Vd/F will be recorded from the PK blood samples collected
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation) Baseline up to Day 21 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
Percentage of Participants With Clinically Significant Changes in Vital Signs Baseline up to Day 21 Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.
Percentage of Participants With Clinically Significant Changes in Physical Examination Baseline up to Day 21 Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be decided by the investigator.
Trial Locations
- Locations (1)
BIOTRIAL
🇫🇷Rennes, France