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    Summary
    EudraCT Number:2022-001883-91
    Sponsor's Protocol Code Number:CLIN-60190-452
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2022-07-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2022-001883-91
    A.3Full title of the trial
    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 Subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Effects of Food on the Bioavailability of Elafibranor in Healthy Subjects.
    A.4.1Sponsor's protocol code numberCLIN-60190-452
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/295/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIpsen Bioscience Inc
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIpsen Bioscience Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Bioscience Inc
    B.5.2Functional name of contact pointClinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressOne Main Street, Suite 700
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.6E-mailclinical.trials@ipsen.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2182
    D.3 Description of the IMP
    D.3.1Product nameElafibranor
    D.3.2Product code IPN60190
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElafibranor
    D.3.9.1CAS number 923978-27-2
    D.3.9.4EV Substance CodeSUB187548
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    This study assesses the effects of food on the effectiveness of elafibranor in healthy adults. It is part of a program to treat adult patients with a liver disease called primary biliary cholangitis.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10036680
    E.1.2Term Primary biliary cirrhosis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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<110 ms, QTcF≤430 ms for male and ≤450 ms for female
    (7) Normal blood pressure (BP) and heart rate (HR) at screening and baseline visits of each period after 5 minutes in supine position: 90 mmHg≤systolic blood pressure (SBP)≤145 mmHg, 50 mmHg≤diastolic blood pressure (DBP)≤90 mmHg, 45 bpm≤HR≤90 bpm. For these parameters, out-of-range values that are not clinically significant (as determined by the investigator) may be repeated twice during screening and baseline visits of each period and the participant may be enrolled if at least one repeated value is within the range noted above.
    (8) Body weight not below 55 kg and body mass index (BMI) within the range 20.0 kg/m2 and 28.0 kg/m2 (inclusive) at screening.
    (9) Contraception/barrier requirements, as specified in the protocol.
    E.4Principal 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 hours before dosing until after collection of the final PK sample in each period.
    (19) Any history or suspicion of alcohol abuse (alcohol consumption >40 g/day). Inability to abstain from alcohol for 24 hours before each period and until after the last sample from each period is collected.
    (20) History of illicit drug abuse within the last 12 months.
    (21) Sensitivity to any components of the study intervention or other allergy that, in the opinion of the investigator, contraindicates participation in the study, including lactose intolerance.
    (22) Inability to abstain from intensive muscular effort. Participants should not engage in any strenuous activity from 72 hours prior to admission to the clinical unit until after their EOS visit.
    (23) Smoker. Smoking or use of tobacco or nicotine-containing products within 3 months prior to or during the study. Status will be confirmed with a urine cotinine at screening and at baseline visits of each period.
    (24) Had been on a diet incompatible with the on-study diet, in the opinion of the investigator or designee, within the 30 days prior to the first dosing and throughout the study.
    (25) Venous status at forearm or dorsal hand making it difficult to insert a venous peripheral catheter.
    (26) Vulnerable subjects, e.g. kept in detention, protected adults under guardianship, trusteeship or committed to an institution by governmental or juridical order.
    E.5 End points
    E.5.1Primary end point(s)
    Noncompartmental PK parameters of elafibranor over 10 days following the study intervention:
    • AUC0-t
    • AUC0-∞
    • Cmax
    E.5.1.1Timepoint(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.
    E.5.2Secondary end point(s)
    Noncompartmental PK parameters of GFT1007 over 10 days following the study intervention:
    • AUC0-t
    • AUC0-∞
    • Cmax

    Noncompartmental PK parameters of elafibranor and GFT1007 over 10 days following the study intervention including, but not limited to:
    • t1/2
    • tmax
    • tlag
    • λz
    • 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
    E.5.2.1Timepoint(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).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Food effect study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The IMP is to be administered in fasting and fed conditions.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state34
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants will not receive any additional study intervention or care following the end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-07
    P. End of Trial
    P.End of Trial StatusCompleted
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