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    Summary
    EudraCT Number:2015-002538-32
    Sponsor's Protocol Code Number:MY-1-2015
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2015-002538-32
    A.3Full title of the trial
    THE EFFECT OF ACYL-GHRELIN ON SODIUM REABSORPTION VIA ENAC IN HEALTHY VOLUNTEERS
    IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, CROSS-OVER STUDY

    ACYL-GHRELINS EFFEKT PÅ NATRIUMREABSORPTIONEN VIA ENAC HOS RASKE FORSØGSPERSONER I ET RANDOMISERET, DOBBELTBLINDET, PLACEBOKONTROLLERET OVERKRYDSNINGSSTUDIUM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE EFFECT OF ACYL-GHRELIN ON SODIUM REABSORPTION VIA ENAC IN HEALTHY VOLUNTEERS
    ACYL-GHRELINS EFFEKT PÅ NATRIUMREABSORPTIONEN VIA ENAC HOS RASKE FORSØGSPERSONER
    A.4.1Sponsor's protocol code numberMY-1-2015
    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 SponsorMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.1.3.4CountryDenmark
    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 supportMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicinsk Forskningsafsnit, Regionshospitalet Holstebro (Department of Medical Research, Regional Hospital Holstebro)
    B.5.2Functional name of contact pointMy Emma Sofie Malmberg
    B.5.3 Address:
    B.5.3.1Street AddressLægårdvej 12
    B.5.3.2Town/ cityHolstebro
    B.5.3.3Post code7500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004578436588
    B.5.6E-mailmymalmbe@rm.dk
    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 Amilorid Mylan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameAmilorid Mylan
    D.3.4Pharmaceutical form 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 INNAmilorid Mylan
    D.3.9.1CAS number 2016-88-8
    D.3.9.3Other descriptive nameAMILORIDE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00445MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    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 nameAcyl-Ghrelin
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman Ghrelin Acetate
    D.3.9.1CAS number 258289-04-8
    D.3.9.3Other descriptive nameGhrelin
    D.3.9.4EV Substance CodeSUB167591
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboTablet
    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
    The physiological responses to Acyl-ghrelin-injection on the sodium reabsorption via ENaC in healthy subjects.
    De fysiologiske effekter af Acyl-Ghrelin-injektion på natriumreabsorption via ENaC hos raske forsøgspersoner.
    E.1.1.1Medical condition in easily understood language
    The physiological responses to Acyl-ghrelin-injection on the sodium reabsorption via ENaC in healthy subjects.
    De fysiologiske effekter af Acyl-Ghrelin-injektion på natriumreabsorption via ENaC hos raske forsøgspersoner.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10022891
    E.1.2Term Investigations
    E.1.2System Organ Class 10022891 - Investigations
    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 Acyl-ghrelin on the sodium reabsorption via ENaC in a randomized, placebo-controlled, double-blind, cross-over study in healthy subjects, by measuring kidney functions, blood pressure and vasoactive hormones.
    At undersøge Acyl-Ghrelins effekt på natriumreabsorption via ENaC, i et randomiseret, placebo-kontrolleret, dobbelt-blindet, overkrydset forsøg hos raske forsøgspersoner, ved måling af nyrefunktion, blodtryk samt vasoaktive hormoner.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ikke relevant
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18-40 years, BMI 18,5-30kg/m2, women must use contraception.
    Alder 18-40år, BMI 18,5-30 kg/m2, kvinder skal anvende sikker antikonceptiva.
    E.4Principal exclusion criteria
    Tobacco smoking, substance abuse, consumption of more than 7 units of alcohol/week for women and more than 14 units/week for men, medical treatment except for contraception, pregnancy or nursing, allergy to acyl-ghrelin, significant clinical signs of heart-, lung-, liver-, kidney-, endocrine-, brain- or neoplastic disorders, clinically significant abnormal findings in screening blood samples, urine sample or ECG, office blood pressure over 140/90 mmHg, donation of blood within 1 month of the first day of investigation.
    Tobaksrygning, stofmisbrug, alkoholoverforbrug, dvs. >7 genstande/uge for kvinder og > 14 genstande/uge for mænd, i fast medicinsk behandling fraset antikonceptiva, graviditet eller amning, allergi overfor acyl-ghrelin, betydende kliniske tegn på hjerte-, lunge-, lever-, nyre-,
    endokrinologiske-, hjerne- eller neoplastiske lidelser, klinisk betydende abnorme fund ved screeningsblodprøver, urinprøve eller EKG, konsultationsblodtryk over 140/90 mmHg, bloddonation indenfor den seneste måned inden første undersøgelsesdag.
    E.5 End points
    E.5.1Primary end point(s)
    Fractional sodium excreation (FENa)
    Fraktionel natriumeksretion (FENa)
    E.5.1.1Timepoint(s) of evaluation of this end point
    When all subjects have completed and the blood and urine samples have
    been analyzed.
    Når alle forsøgsperosner er afsluttet og blod- samt urinprøver
    analyseret.
    E.5.2Secondary end point(s)
    Augmentation index, brachial blood pressure, central blood pressure, heart rate, pulse wave velocity, free water clearance, potassium clearance, sodium clearance, fractional excretion of potassium, fractional excretion of sodium, glomerular filtration rate, plasma levels of acylghrelin, plasma levels of aldosterone, plasma levels of angiotensin II , plasma concentrations of vasopressin, plasma concentrations of atrial natriutisk peptide,plasma levels of brain natriuretic peptide, plasma levels of renin, plasma concentration of ghrelin and acyl-ghrelin, urinary excretion of aquaporin2, urinary excretion of ENaC (epithelial sodium
    channel), urinary concentration of NCC (sodium chloride co-transporter) and NKCC2 (natriumkalium2klorid co-transporter) and urine volume.
    Augmentation index, brachialt blodtryk, centralt blodtryk, puls, pulsbølgehastighed, frit vand clearance, kalium clearance, natrium clearance, fraktionel ekskretion af kalium, fraktionel ekskretion af natrium, glomerulær filtrationshastighed, plasmakoncentration af acylghrelin, plasmakoncentration af aldosteron, plasmakoncentration af angiotensin II, plasmakoncentration af vasopressin, plasmakoncentration af atrial natriutisk peptid,plasmakoncentration af brain
    natriuretisk peptid, plasmakoncentration af renin, plasmakoncentrationen af ghrelin og acyl-ghrelin, urinudskillelse af aquaporin2, urinudskillelse af ENaC (epiteliale natriumkanal), urinkoncentration af NCC (natriumklorid co-transporteren) og NKCC2 (natriumkalium2klorid co-transporteren) og urin volume.
    E.5.2.1Timepoint(s) of evaluation of this end point
    When all subjects have completed and the blood and urine samples have been analyzed.
    Når alle forsøgsperosner er afsluttet og blod- samt urinprøver analyseret.
    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 Yes
    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) 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 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.8.2.4Number 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 20
    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 state20
    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
    Ingen
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-15
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