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    Summary
    EudraCT Number:2007-003237-16
    Sponsor's Protocol Code Number:GFT505-207-1
    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:2007-07-23
    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 number2007-003237-16
    A.3Full title of the trial
    A Pilot study to evaluate the Efficacy and Safety of GFT505 (30 mg) orally administered for 28 days in patients with Frederickson Type IIb Dyslipidemia (Mixed Hyperlipidemia). A double blind, placebo-controlled and randomized study.
    A.4.1Sponsor's protocol code numberGFT505-207-1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGENFIT
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGFT505
    D.3.2Product code GFT505
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 824932-88-9
    D.3.9.2Current sponsor codeGFT505
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Frederickson Type IIb Dyslipidemia (Mixed Hyperlipidemia).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10027763
    E.1.2Term Mixed hyperlipidemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of GFT505 30 mg in reducing serum TG and increasing HDL-C levels compared with placebo in patients with mixed hyperlipidemia.
    To assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 during 28 days.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of GFT505 30 mg in reducing non-HDL-C and LDL-C levels compared with placebo.
    To describe the evolution in serum TG, HDL-C, LDL-C and non-HDL-C levels.
    To describe the changes in other lipid parameters.
    To evaluate the plasma exposure of GFT505 after repeated once daily administrations of GFT505.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent prior to enrolment
    2. Male or post-menopausal female (defined as >12 months since last menstrual period and with stable (at least 6 months prior to screening) and continuous Hormonal Replacement Therapy if any – surgical removal of ovaries can be considered as “surgical menopause”)
    3. Aged 18 to 75 years
    4. Type IIb Frederickson hyperlipidemia inadequately controlled despite Therapeutic Lifestyle Change (TLC) recommendations (diet and exercise)* - *(documented or highly probable at V1)
    5. Non-hypertensive or patient taking antihypertensive medication maintained at a stable dose for 2 months at least prior to screening (and the stable dose can be maintained throughout the study)
    6. Fasting TG ≥ 200 mg/dL and ≤ 500 mg/dL (2,28 mmol/L ≤ TG ≤ 5,65 mmol/L) at V2
    7. Fasting LDL-C ≥ 130 mg/dL and ≤ 220 mg/dL (3,36 mmol/L ≤ LDL-C ≤ 5,69 mmol/L) at V2
    8. CHD (Coronary Heart Disease) risk lower than 20% at ten years (using Framingham Table) determined using laboratory lipid profile at V2, BP at V2 and medical history collected from the patient
    9. Patient agrees to come to following visits and it is possible to schedule V4 and V5 inside the protocol specified range (14 days +/- 2 days between V3 and V4 ; 14 days +/- 2 days between V4 and V5)
    E.4Principal exclusion criteria
    1. Body Mass Index (BMI) ≥ 35 kg/m2
    2. Known clinical evidence of Coronary Artery Disease prior to or at screening
    3. Blood Pressure > 160 / 95 mmHg
    4. Known alcohol and/or any other drug abuse or dependence. Alcohol consumption of more than 21 alcoholic beverages per week is considered abusive. One alcoholic beverage is defined as 30 mL distilled spirits, 120 mL wine, or 330 mL beer
    5. Type I or Type II diabetes mellitus
    6. Known homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
    7. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
    8. Known history of malignant disease (excluding treated basal cell carcinoma)
    9. Patients who have serious or unstable medical or psychological conditions which, in the opinion of the Investigator, would lead the patient to be non-compliant or uncooperative during the study or would compromise the patient’s safety or successful participation in the study
    10. Patients who have donated blood or blood products within the previous month prior to screening or who plan to donate blood or blood products at any time during the trial and in the 3 months following the end of the study
    11. The Patient is a female of childbearing potential, is pregnant or lactating
    12. Any medication that may interfere with study medication absorption, distribution, metabolism or excretion or could lead to induction or inhibition of microsomial enzymes within 3 months prior to the screening day
    13. Currently taking other investigational drugs or have taken part in a clinical trial within the previous month prior to screening
    14. Known intolerance or contra-indication to the list of excipients of GFT505 (Gelatin, Lactose, Glycerol, Titanium dioxide, Red Iron dioxide)
    15. Patient not covered by Health Insurance System and / or not in compliance with the recommendations of National Law in force
    16. Patient who cannot be contacted in case of emergency
    17. Uncontrolled hypothyroidism defined as TSH > 2 x the upper limit of normal (ULN) at V2 (thyroid dysfunction controlled for at least 6 months prior to screening is permitted)
    18. Significant renal disease, including nephritic syndrome, chronic renal failure and/or serum creatinine >180µmol/L at V2
    19. Active liver disease or hepatic dysfunction as defined by elevations in liver enzymes [alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyltransferase (GGT) and alkaline phosphatase (ALP)] > 2 x the upper limit of normal (ULN) at V2
    20. Unexplained serum creatine kinase (CPK) > 3 x the upper limit of normal (ULN) at V2. Patients with a reason for CPK elevation may continue in screening and have the measurement repeated prior to randomization; a repeat CPK > 3 x ULN is exclusionary
    21. Patient for whom the wash-out period of lipid-regulating drugs (fibrates, statins and other classes of lipid-regulating drugs) has not been respected or who has taken any other drug that is known to affect the lipid metabolism
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY:

    Primary Endpoint:
    - Decrease in serum TG level from baseline to D28 (V5)
    - Increase in serum HDL-C level from baseline to D28 (V5)

    Secondary Endpoints:
    - Decrease in serum non-HDL-C and LDL-C levels from baseline to D28 (V5)
    - Changes from baseline to all study visits for other lipids (TG, HDL-C, Total Cholesterol, FFA) and special lipids (small dense LDL, remnants, Apo AI, Apo AII, Apo B, Apo CIII,, Apo CIII/B, Apo CIII-nonB)

    SAFETY:
    - SAE, AE, physical examination, vital signs, medical history, ECG
    - Hematology (WBC and differential count, RBC, hemoglobin, hematocrit and platelets, haptoglobin, prothrombin, reticulocytes count) and biochemical markers (plasma glucose, HbA1c, insulin, CPK, AST, ALT, GGT, TSH, alkaline phosphatases, creatinine, troponin, total and conjugated bilirubin, urea, uric acid, albumin, homocystein, fibrinogen, total proteins, electrolytes (sodium, potassium, chloride, calcium)) and urinalysis.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned25
    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 Information not present in EudraCT
    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
    The end of the trial corresponds to the Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state30
    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 Decision2007-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-15
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