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    Summary
    EudraCT Number:2016-003215-35
    Sponsor's Protocol Code Number:PXL008-017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-10-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-003215-35
    A.3Full title of the trial
    A phase 2a, randomised, double-blind, placebo-controlled, cross-over, single and multiple dose study to assess the effects of imeglimin on nicotine-induced endothelial dysfunction in young non-smoker healthy male subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2a, randomised, double-blind, placebo-controlled, cross-over, single and multiple dose study to assess the effects of imeglimin on nicotine-induced endothelial dysfunction in young non-smoker healthy male subjects.
    A.4.1Sponsor's protocol code numberPXL008-017
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPoxel
    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 supportPoxel
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPoxel
    B.5.2Functional name of contact pointDr. med Pascale Fouqueray
    B.5.3 Address:
    B.5.3.1Street Address259/261 avenue Jean Jaurès
    B.5.3.2Town/ cityLyon
    B.5.3.3Post code69007
    B.5.3.4CountryFrance
    B.5.4Telephone number+33698017103
    B.5.6E-mailpascale.fouqueray@poxelpharma.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameImeglimin
    D.3.2Product code PXL008
    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 INNIMEGLIMIN
    D.3.9.1CAS number 775351-61-6
    D.3.9.2Current sponsor codePXL008
    D.3.9.3Other descriptive nameIMEGLIMIN
    D.3.9.4EV Substance CodeSUB31216
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Diabetes Mellitus, Type 2
    E.1.1.1Medical condition in easily understood language
    Diabetes Type 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 100000004861
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Assessment of the effect of a single oral dose of 1500 mg imeglimin on brachial artery endothelial function measured with flow-mediated dilation (FMD) before and after administration of 2 mg nicotine.
    • Assessment of the effect of multiple (8 to 11 days) oral doses of 1500 mg b.i.d. imeglimin on brachial artery endothelial function measured with FMD before and after administration of 2 mg nicotine.
    E.2.2Secondary objectives of the trial
    • Assessment of the effect of a single oral dose of 1500 mg imeglimin on augmentation index (Aix@75) and pulse wave velocity (PWV) before and after administration of 2 mg nicotine.
    • Assessment of the effect of multiple oral doses of 1500 mg b.i.d. imeglimin on augmentation index (Aix@75) and pulse wave velocity (PWV) before and after administration of 2 mg nicotine.
    • Assessment of the effect of a single oral dose of 1500 mg imeglimin on endothelium independent dilation.
    • Assessment of the effect of multiple oral doses of 1500 mg b.i.d. imeglimin on endothelium independent dilation.
    • Assessment of the effect of imeglimin on hsCRP.
    • Assessment of the safety and tolerability of imeglimin after a multiple administration of 1500 mg b.i.d. imeglimin.
    • Determination of the imeglimin plasma concentrations after a single administration and a multiple administration of 1500 mg imeglimin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent obtained before any trial-related activities.
    2. Healthy male subjects, as judged by the investigator based on medical history, physical examination, vital signs, ECG and biological parameters.
    3. Caucasian.
    4. Right-handedness.
    5. Non-smoker for the last 15 years (defined as neither having smoked nor having used nicotine substitute products regularly or occasionally).
    6. Age between 18 and 35 years, both inclusive.
    7. Body Mass Index (BMI) between 18.5 and 25 kg/m^2, both inclusive.
    8. Estimated glomerular filtration rate ≥ 80 mL/min/1.73 m^2 (according to the CKD-EPI formula).
    9. Agreeing to use highly effective contraceptive methods as defined by the investigator and according to local guidelines until the end of the study (after follow-up visit).
    E.4Principal exclusion criteria
    1. Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological, haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness as judged by the Investigator.
    2. Supine blood pressure at screening (after resting for at least 5 min in supine position) outside the ranges for systolic 100-140 mmHg blood pressure and/or for diastolic blood pressure greater than 90 mmHg (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial).
    3. Heart rate at rest outside the range of 50-90 beats per minute.
    4. History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome
    5. Clinically significant abnormal haematology, biochemistry or coagulation screening tests, as judged by the Investigator. In particular, elevated liver enzymes (AST, ALT or ALP > 1.5 times the upper limit of normal).
    6. A positive result of the alcohol breath test or urine drug screen at the screening visit.
    7. A positive cotinine urine test at the screening visit.
    8. Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening, as judged by the Investigator.
    9. Acute infection within the last 2 weeks.
    10. Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
    11. Known hypersensitivity to any of the constituents or excipients of the study IMPs, nicotine or glycerotrinitrate or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions).
    12. Use of any prescription or non-prescription medication (including vitamins and herbal therapies) within 14 days prior to screening visit (the occasional use of paracetamol is not prohibited if judged acceptable by the investigator).
    13. Positive to the screening test for Hepatitis Bs antigen or Hepatitis C antibodies and/or a positive result to the test for HIV-1/2 antibodies or HIV-1 antigen.
    14. Significant history of alcoholism or drug abuse as judged by the Investigator or consuming more than 14 units of alcohol per week (one unit of alcohol equals about 330 mL of beer, one glass of wine of 120 mL, or 40 mL spirits).
    15. Blood donation or blood loss of more than 500 mL within the last 30 days to screening visit.
    16. Previous participation in this trial. Participation is defined as randomised.
    17. Receipt of any medicinal product in clinical development within 30 days before randomisation in this trial.
    18. Insufficient ultrasound imaging quality of subject’s brachial artery for FMD analysis as assessed by a screening ultrasound measurement and judged by the Investigator.
    E.5 End points
    E.5.1Primary end point(s)
    1) % change in FMD at the first treatment day before and after administration of 2 mg nicotine with imeglimin treatment compared to placebo.
    2) % change in FMD at the last treatment day before and after administration of 2 mg nicotine with imeglimin treatment compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) at the first treatment day before and after trial drug administration
    2) at the last treatment day before and after trial drug administration
    E.5.2Secondary end point(s)
    1) % change in FMD at the last treatment day before and after administration of 2 mg nicotine compared to the first treatment day.
    2) % change in Aix@75 and PWV at the first treatment day before and after administration of 2 mg nicotine with imeglimin treatment compared to placebo.
    3) % change in Aix@75 and PWV at the last treatment day before and after administration of 2 mg nicotine with imeglimin treatment compared to placebo.
    4) % change in Aix@75 and PWV at the last treatment day before and after administration of 2 mg nicotine compared to the first treatment day.
    5) % change in endothelium independent dilation relative to baseline after administration of 0.4 mg glycerotrinitrate measured at the first treatment day with imeglimin treatment compared to placebo.
    6) % change in endothelium independent dilation relative to baseline after administration of 0.4 mg glycerotrinitrate measured at the last treatment day with imeglimin treatment compared to placebo.
    7) hsCRP at the first treatment day and last treatment day in imeglimin treatment versus placebo.
    8) Imeglimin plasma concentrations 2 hours after the first dose and pre-dose and 2 hours after the last study drug administration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) at the last treatment day before and after trial drug administration
    2) at the first treatment day before and after trial drug administration
    3) at the last treatment day before and after trial drug administration
    4) at the last treatment day before and after trial drug administration
    5) at the first treatment day with imeglimin treatment
    6) at the last treatment day with imeglimin treatment
    7) at the first treatment day and last treatment day in imeglimin treatment
    8) 2 hours after the last study drug administration
    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 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 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single and multiple dose
    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.8.2.4Number 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 months5
    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: 18
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state18
    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)
    None
    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 Decision2016-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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