This is a study to evaluate the effects of food on the bioavailability of elafibranor in healthy adult participants. It is part of a clinical development program for the IMP, the intended indication of which is for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. MedDRA version: 21.0 Level: LLT Classification code 10036680 Term: Primary biliary cirrhosis S
Conditions
Interventions
Product Name: Elafibranor
Product Code: IPN60190
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Elafibranor
CAS Number: 923978-27-2
Concentration unit: mg milligram(s)
Concentration type
Sponsors
Ipsen Bioscience Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: (1) Male or female participants must be 18 to 45 years of age (inclusive) at the time of signing the informed consent. Sex ratio must be at least 40% of each gender. (2) Has provided signed informed consent as described in Appendix 10.1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. (3) Willingness to remain at the clinic for the required duration and willingness to return to the clinic for the follow-up evaluation as specified in the protocol. (4) Healthy participants as determined by medical evaluation at the screening visit including medical history, physical examination, laboratory tests, electrocardiogram (ECG) and vital signs monitoring. (5) Laboratory parameters within the normal range of the laboratory (haematological, blood biochemistry, urinalysis) at screening and baseline visit of each period. Individual values out of the normal range can be accepted if judged not clinically significant by the investigator. (6) Normal electrocardiogram (ECG) recording on a 12-lead ECG at screening and baseline visit of each period: 120=PR=220 ms, QRS=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are excluded from the study if any of the following criteria apply: Medical Conditions (1) History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, haematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. (2) Lymphoma, leukaemia or any malignancy within the past 5 years except basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years prior to screening. (3) Breast cancer within the past 10 years at screening. (4) Major surgery within 28 days prior to screening. Prior/Concomitant Therapy (5) Past or intended use of over the counter (OTC) or prescription medication (including herbal medications or vitamin supplements, nutritional supplements, herb-containing drug preparations (including Chinese medicines)) within 14 days or 5 half-lives of the drug (whichever is longer) prior to dosing. Exceptions are oral contraception/hormone replacement therapy for females and paracetamol/acetaminophen at doses of =2 g/day. (6) Any vaccination during the 4 weeks before randomisation or planned during the clinical study. (7) Use of any medications within 3 months that may interfere with absorption, distribution, metabolism or excretion of the study intervention, or any medication that may result in induction or inhibition of microsomal enzymes. Prior/Concurrent Clinical Study Experience (8) Plasma donation within 14 days of the screening or any blood donation/blood loss >450 mL during the last 30 days before screening. Blood and/or plasma should not be donated until 30 days after last study intervention. (9) Current enrolment or past participation within the last 3 months (or 5 half-lives, whichever is longer) before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research. (10) Participant who would receive more than 4500 Euro as indemnities for participation in biomedical research within the last 12 months, including the indemnities for the present study. Diagnostic Assessments (11) Presence of hepatitis B surface antigen (HBsAg) at screening. (12) Positive hepatitis C antibody test result at screening. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained and sustained viral response can be documented. (13) Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. NOTE: Test is optional and participants with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing. (14) Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigen test result at screening or during the study. (15) Positive drugs of abuse/alcohol screen at screening and baseline visit of each period. (16) Positive human immunodeficiency virus (HIV) antibody test at screening. Other Exclusions (17) Consumption of other foods or beverages that may affect drug-metabolising enzymes or transporters from 7 days prior to dosing until the end of each study period. (18) Inability to abstain from caffeine- or xanthine-containing products (e.g. coffee, tea, cola drinks and chocolate) for 24 hou
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the bioavailability of a single dose of the to-be-marketed tablet of elafibranor 80 mg administered in fasting and fed conditions and to assess the PK parameters of elafibranor for total exposure and peak exposure.;Secondary Objective: To assess the PK parameters of elafibranor’s main active metabolite GFT1007 for total exposure and peak exposure under fasting and fed conditions. To assess other relevant PK parameters of elafibranor and its main active metabolite GFT1007 after administration of a single dose of the to-be-marketed tablet of elafibranor 80 mg in fasting and fed conditions. To assess the safety and tolerability of a single dose of the to be marketed tablet of elafibranor 80 mg administered in fasting and fed conditions in healthy participants.;Primary end point(s): Noncompartmental PK parameters of elafibranor over 10 days following the study intervention: • AUC0-t • AUC0-8 • Cmax;Timepoint(s) of evaluation of this end point: On Day 3, Day 4, Day 6, Day 8 and Day 10 the participants will come to the study centre for PK sampling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Noncompartmental PK parameters of GFT1007 over 10 days following the study intervention: • AUC0-t • AUC0-8 • Cmax Noncompartmental PK parameters of elafibranor and GFT1007 over 10 days following the study intervention including, but not limited to: • t1/2 • tmax • tlag • ?z • Cl/F • Vd/F Number and percentages of participants with TEAEs and AESI up to EOS Number and percentages of participants with clinically significant changes from baseline up to Day 10 in each period in: • laboratory assessments (haematology, blood biochemistry and urinalysis) • vital signs (SBP and DBP, pulse rate) • 12 lead ECG • physical examination;Timepoint(s) of evaluation of this end point: Collectively, the above endpoints will be assessed throughout the duration of the study (from screening to end of study). Further details are provided in the schedule of activities (pages 13-15 of the protocol). | — |
Countries
France
Contacts
Public ContactClinical Trials
Ipsen Bioscience Inc
Outcome results
None listed