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    Summary
    EudraCT Number:2017-001437-12
    Sponsor's Protocol Code Number:Ex17
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-04-13
    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 ConcernedEstonia - SAM
    A.2EudraCT number2017-001437-12
    A.3Full title of the trial
    Effect of exenatide on cortisol secretion
    Eksenatiidi toime kortisooli sekretsioonile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of exenatide on cortisol secretion
    Eksenatiidi toime kortisooli sekretsioonile
    A.4.1Sponsor's protocol code numberEx17
    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 SponsorUniversity of Tartu
    B.1.3.4CountryEstonia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity of Tartu
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Tartu
    B.5.2Functional name of contact pointDepartment of Physiology
    B.5.3 Address:
    B.5.3.1Street AddressRavila 19
    B.5.3.2Town/ cityTartu
    B.5.3.3Post code50411
    B.5.3.4CountryEstonia
    B.5.6E-mailvallo.volke@ut.ee
    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 Yes
    D.2.1.1.1Trade name Byetta
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameByetta
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    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
    Healthy volunteers
    Terved vabatahtlikud
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers
    Terved vabatahtlikud
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to test whether exenatide (10 micrograms s.c) stimulates ACTH /cortisol release and what is the magnitude of cortisol response in healthy volunteers. If the response is comparabele to the responses reported during glucagon stimulation test, there is a potential to use the drug to test for secondary adrenal insufficiency.
    Eesmärgiks on uurida tervetel vabatahtlikel, kas eksenatiidi manustamine kutsub esile AKTH ja kortisooli tasemete olulise kõrgenemise. Juhul kui efekti tugevus on sarnane teaduskirjanduses publitseeritud glükagooni stimulastioonitestil saadud tulemustega, oleks eksenatiidi võimalik kasutada tsentraalse neerupealiste puudulikkuse testina.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ei ole kohaldatav
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age 18-50 years
    2) Bodyweight >65 kg
    1) Vanus 18-50 aastat
    2) Kehakaal >65 kg
    E.4Principal exclusion criteria
    1) Existence of chronic disease
    2) Existence of drugs used daily
    3) Pregnancy, lactation
    4) Use of oral contraceptives during two month before the study
    1) Kroonilise haiguse olemasolu
    2) Igapäevaselt tarvitatavate ravimite olemasolu
    3) Rasedus, imetamine
    4) Suukaudsete kontratseptiivide kasutamine eelneva 2 kuu jooksul
    E.5 End points
    E.5.1Primary end point(s)
    Maximum level of cortisol after single exenatide injection
    Maksimaalne kortisooli tase peale eksenatiidi ühekordset manustamist
    E.5.1.1Timepoint(s) of evaluation of this end point
    The blood samples for measuring cortisol level are taken before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.
    Vereanalüüsid kortisooli määramiseks võetakse enne eksenatiidi manustamist ja 30, 60, 90 ning 120 minutit peale seda.
    E.5.2Secondary end point(s)
    Levels of other related hormonal and biochemical markers and changes in heart rate and blood pressure after exenatide single administration (incl. glucose, ACTH).
    Teiste seotud hormonaalsete ja biokeemiliste markerite tasemed ja muutused südame löögisageduses ning vererõhus peale eksenatiidi manustamist (sh glükoos, AKTH).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The blood samples for measuring hormonal and biochemical markers are taken and blood pressure and heart rate are measured before the exenatide injection and 30, 60, 90 and 120 minutes after the administration.
    Vereanalüüsid hormonaalsete ja biokeemiliste markerite määramiseks võetakse ning vererõhku ja südame löögisageduse väärtused mõõdetakse enne eksenatiidi manustamist ja 30, 60, 90 ning 120 minutit peale seda.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 No
    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 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
    LVLS
    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 months8
    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 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: 10
    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 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 state10
    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
    Puudub
    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 Decision2017-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-15
    P. End of Trial
    P.End of Trial StatusOngoing
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