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    Summary
    EudraCT Number:2007-000536-95
    Sponsor's Protocol Code Number:SLx-4090-07-03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-19
    Trial 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 ConcernedGermany - BfArM
    A.2EudraCT number2007-000536-95
    A.3Full title of the trial
    A randomised, double-blind, placebo controlled study to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics profile of SLx-4090 over 14 days dosing in subjects with high triglyceride values.
    A.4.1Sponsor's protocol code numberSLx-4090-07-03
    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 SponsorSurface Logix
    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 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 nameSLx-4090
    D.3.2Product code SLx-4090
    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.3.9.2Current sponsor codeSLx-4090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Dyslipidemia/hypertriglyceridemia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10058110
    E.1.2Term Dyslipidemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of repeat oral doses of SLx-4090 200 mg tid and 200 mg od for 14 days on plasma triglycerides in subjects with high triglyceride values.
    E.2.2Secondary objectives of the trial
    •To investigate the effect of repeat oral doses of SLx-4090 for 14 days on additional pharmacodynamic parameters (high density lipoprotein (HDL), LDL, total cholesterol and ApoB lipoprotein) in subjects with high triglyceride values.
    • To determine the safety and tolerability of repeat oral doses of SLx-4090 for 14 days in subjects with high triglyceride values.
    • To investigate the pharmacokinetics of repeat oral doses of SLx-4090 for 14 days in subjects with high triglyceride values.
    • To determine changes in pharmacodynamic and pharmacokinetic profiles following daily tid and od doses of SLx-4090 and on a day where all administered meals have a high fat content (Day 10).
    • To investigate the effects of SLx-4090 on the composition, including the fat and lipid composition, of feces following Day 1 (placebo), 2 and 15 daily doses of SLx-4090 in male and female patients with hypertriglyceridemia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged between 18 and 65 years, inclusive.
    Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal defined as 12 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels > 40 mIU/mL and estrogen levels < 30 pg/mL or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.
    or
    Male partners of female subjects must use a condom/spermicide during sexual intercourse with females of childbearing potential in addition to the subject using a second form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, sub-dermal implants or a tubal ligation if engaging in sexual intercourse. This criterion must be followed from the time of the first dose of study medication until 30 days after the last dose of study medication.
    2. Plasma triglyceride concentration of 150 – 900 mg/dL at Screening with a change of no more than 25% from the Screening assessment on Day -4. Subjects who have triglyceride concentrations below the 250 mg/dL or above the 900 mg/dL thresholds on Day -4, but whose levels have changed not more than 10% from Screening, may be included at the Investigators discretion.
    3. Void
    4. Body weight within a body mass index range of 19 – 35 kg/m2, inclusive.
    5. Total cholesterol of more than 200 mg/dL.
    6. Low density lipoprotein cholesterol (LDL-C) of > 130 mg/dL
    7. A 12-lead ECG at the pre-study medical, which in the opinion of the Investigator had no abnormalities that will compromise safety in this study.
    8. A negative pre-study urine drugs of abuse screen within 21 days of study start.
    9. Negative pre-study hepatitis B antigen, hepatitis C test and human immunodeficiency virus tests.
    10. Available to complete all study measurements.
    11. Willing and able to comply with a standardized diet.
    12. Able to provide written informed consent prior to the performance of any study specific procedures.
    E.4Principal exclusion criteria
    1. Past or present disease (e.g., clinically significant forms of atherosclerotic disease, malignancy, gastrointestinal surgery or disease) that is judged by the Investigator to have the potential to interfere with the study procedures, compromise safety, or affect the pharmacokinetic and pharmacodynamic evaluations.
    2. Uncontrolled hypertension with blood pressure higher than 160/95 mmHg or poorly controlled diabetes with HbA1C > 9% at Screening.
    3. Active pancreatitis.
    4. Presence of overt proteinuria (> 200 mg/L) at Screening.
    5. Glomerular filtration rate of ≤ 40 mL/minute at screening (calculated using Cockkroft and Gault's formula).
    6. Screening liver function tests alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl-transferase (GGT) exceeding three-times the upper limit of the normal range.
    7. Abuse of alcohol, defined as a maximum weekly intake of greater than 140 g or an average daily intake of greater than 20 g (20 g alcohol are contained in 0.5 L of 5° beer or 3 measures of spirits 40° or 0.25 L wine 10°).
    8. A history of drug abuse.
    9. Any prescribed or over the counter medication taken within 2 weeks prior to the administration of study drug or within 6 times the elimination half life of the medication prior to the study drug intake (whichever is longer). Exceptions will include any concomitant medication that fulfils the criteria described in Section 4.2.4.
    10. History or presence of gastro-intestinal, hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
    11. Exposure to any new chemical entities within 12 months prior to the first dosing day.
    12. Participation in a trial with any drug within 3 months before the start of the study.
    13. Blood donation of more than 500 mL blood in the previous 3 months.
    14. Subjects attempting to father a child during and up to 3 months after the study
    15. Any confirmed significant allergic reaction against any drug or multiple allergies.
    16. Subjects do not report to the unit fasting on the evening of Day -1 and/or do not provide a diary card with sufficient information to derive their average daily food intake.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma triglyceride concentrations: on Day 1 after placebo dosing, on Day 2 following SLx-4090 (or placebo) and on Day 15, after repeat dosing for 14 days.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 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 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
    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 months4
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    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 state24
    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 Decision2007-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-12
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