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    Summary
    EudraCT Number:2013-002260-10
    Sponsor's Protocol Code Number:MCL-metoprolol-IR
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-06-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002260-10
    A.3Full title of the trial
    The effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol from an immediate release tablet in female bariatric patient volunteers: a single oral dose study before and after surgery.
    Onderzoek naar de invloed van een gastric bypass op de opname in het lichaam van het geneesmiddel metoprolol met directe afgifte.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the effect of gastric bypass on the absortpion of metoprolol immediate release tablet.
    Onderzoek naar de invloed van een gastric bypass op de opname in het lichaam van het geneesmiddel metoprolol met directe afgifte.
    A.3.2Name or abbreviated title of the trial where available
    Effect of RYGB on the absorption of metoprolol immediate release.
    Invloed van een gastric bypass op de absorptie van metoprolol directe afgifte.
    A.4.1Sponsor's protocol code numberMCL-metoprolol-IR
    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 SponsorMedisch Centrum Leeuwarden
    B.1.3.4CountryNetherlands
    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 supportWetenschapsfonds MCL
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedisch Centrum Leeuwarden
    B.5.2Functional name of contact pointMCL Academie
    B.5.3 Address:
    B.5.3.1Street AddressH. Dunantweg 2
    B.5.3.2Town/ cityLeeuwarden
    B.5.3.3Post code8934 AD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31582866666
    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 Metoprolol tartraat 100 mg tablet
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Roux-en-Y gastric bypass
    Roux-en-Y gastric bypass operatie
    E.1.1.1Medical condition in easily understood language
    overweight surgery (Roux-en-Y gastric bypass)
    overgewicht operatie (Roux-en-Y gastric bypass)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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
    To investigate the effect of Roux-en-Y gastric bypass on the rate and extent of absorption of metoprolol and its main active metabolite α-OH metoprolol after a single oral dose of 100 mg of metoprolol IR tablet in 10 female bariatric surgery patient volunteers, before and after surgery.


    The pharmacokinetic parameters that will be determined are:
    - Cmax The maximum serum concentration of metoprolol.
    - Tmax The time after oral administration of metoprolol when the maximum serum concentration is reached.
    - AUC t=0-10 The area under the serum concentration-time curve, a measurement of the bioavailability of metoprolol until 10 hours after intake.

    The effect can be determined according to the ratios as listed in the study protocol.
    Primaire doel: Het bepalen van het effect van een Roux-en-Y gastric bypass op de snelheid en mate van absoprtie van metoprolol en diens metaboliet α-OH metoprolol na inname ven een eenmalige orale dosis van 100 mg metoprolol in de vorm van een directe afgifte tablet aan 10 vrouwelijke vrijwillige bariatrische chirurgie patiënten, voor en na de operatie.

    De farmacokinetische parameters die worden bepaald zijn:
    - Cmax De maximum serum concentratie van metoprolol en diens metaboliet.
    - Tmax De tijd na orale toediening van metoprolol wanneer de maximum serum concentratie is bereikt.
    - AUC t=0-10 Het oppervlak onder de serum concentratie-tijd curve, een maat voor de biologische beschikbaarheid van metoprolol tot 10 uur na
    inname.

    Het effect kan worden vastgesteld met behulp van de ratio's zoals aangegeven in het studieprotocol.
    E.2.2Secondary objectives of the trial
    not applicable
    niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Ten female bariatric surgery patient volunteers will participate in this study.

    Inclusion criteria
    - Female gender
    - Age 18-50 years
    - Scheduled for Roux-en-Y gastric bypass surgery
    - Good liver and kidney function
    - Normal ECG
    - Intermediate or extensive CYP 2D6 metabolizer, evidenced by genotyping.
    Tien vrijwillige vrouwelijke bariatrische chirurgie patiënten zullen aan de studie meedoen.

    Inclusie criteria
    vrouwelijk geslacht
    - leeftijd tussen 18 en 50 jaar
    - gepland voor een Roux-en-Y gastric bypass operatie
    - goede lever- en nierfunctie
    - normaal ECG
    - langzame of normale metaboliseerder van CYP2D6, zoals vastgesteld door genotypering
    E.4Principal exclusion criteria
    Exclusion criteria
    - Pregnancy
    - Smoking
    - Alcohol: more than 7 drinks a week or 4 or more drinks during a single occasion
    - Use of alcohol during the period 24 hours before until 48 hours after the start of each phase of the study
    - Use of metoprolol
    - The use of CYP 2D6 inhibiting, inducing or metabolising drugs
    - The use of drugs that may interact with metoprolol
    o Calcium antagonist
    o Lidocaine
    o Digoxin
    - Use of a proton pump inhibitor
    - Use of laxatives
    - An existing contraindication for the use of metoprolol
    o Sick-sinus syndrome
    o Second and third degree heart block
    o Systolic blood pressure less than 100 mmHg
    o Cardiogenic shock
    o Sinus bradycardia
    o Cardiac failure, overt
    o Cardiac failure, moderate to severe
    o Untreated pheochromocytoma
    o Heart rate less than 45 beats/minute
    o First degree heart block (P-R interval 0.24 sec or greater)
    o Severe bronchial asthma or a history of severe bronchospasm
    o Hypersensitivity to metoprolol, related derivatives, other beta-blockers, or any component of the product
    o Severe peripheral arterial circulatory disorders
    - Previous surgery of the upper gastrointestinal tract
    - Disease or any other condition that may interfere with gastrointestinal absorption
    - Suffering from dumping syndrome after RYGB surgery
    Exclusie criteria
    - zwangerschap
    - roken
    - Alcohol: meer dan 7 eenheden per week of 4 eenehden per keer
    - gebruik van alcohol in de periode van 24 uur voor tot 48 uur na de start van iedere fase van de studie
    - gebruik van metoprolol
    - het gebruik van CYP 2D6 remmende, inducerende of metaboliserende geneesmiddelen
    - het gebruik van geneesmiddelen die mogelijk een interactie geven met metoprolol
    o Calciumantagonist
    o Lidocaine
    o Digoxine
    - het gebruik van een protonpompremmer
    - het gebruik van een laxans
    - een bestaande contraindicatie voor het gebruik van metoprolol
    o Sick-sinus syndroom
    o tweede en derde graad hart block
    o Systolische bloeddruk minder dan 100 mmHg
    o Cardiogene shock
    o Sinus bradycardie
    o duidelijk hartfalen
    o hartfalen matig tot ernstig
    o onbehandelde feochromocytoom
    o hartslag minder dan 45 slagen per minuut
    o eerste graads hart block (P-R interval 0.24 sec of langer)
    o ernstig bronchiaal asthma of een voorgeschiedenis van ernstige bronchospasmen
    o overgevoeligheid voor metoprolol, verwante verbindingen, andere betablokkers, of een hulpstof van het product
    o ernstige perifere vaataandoening
    - eerdere operatie van het maagdarmkanaal
    - ziekte of enige aandoening die zou kunnen interfereren met gastrointestinale absorptie
    - lijdend aan het dumping syndroom na de RYGB operatie
    E.5 End points
    E.5.1Primary end point(s)
    Parameters that will be determined before and after surgery are Cmax, Tmax, and
    AUC0-10 of metoprolol and its main active metabolite α-OH metoprolol.

    The main endpoint is the ratio of AUCafter/AUCbefore of metoprolol and α-OH metoprolol.
    Parameters die voor en na de operatie zullen worden bepaald zijn Cmax, Tmax, en AUC0-10 van metoprolol en diens belangrijkste actieve metaboliet α-OH metoprolol.

    De belangrijkste uitkomstmaat is de ratio van de AUCna/AUCvoor van metoprolol en α-OH metoprolol.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After last visit of last subject.
    Na de laatste fase van de laatste patiënt
    E.5.2Secondary end point(s)
    Secondary endpoint is the quotient of the ratios of the AUC of metoprolol and its metabolite after and before.


    Other study parameters
    Blood pressure and heart rate measured at t = 0, 2, 4, 8 and 10 hours after intake of metoprolol.

    Further analysis
    After completion of the other pharmacokinetic study with metoprolol controlled release tablet relevant parameters may be compared for further analysis.
    Het secundaire eindpunt is het quotiënt van de ratio's van de AUC van metoprolol en diens metaboliet na en voor de operatie.


    Andere studieparameters:
    Bloeddruk en hartslag bepaald op t = 0, 2, 4, 8 en 10 uur na inname van metoprolol.

    Verdere analyse
    Na voltooiïng van de andere farmacokinetische studie met metoprolol gecontroleerde afgifte kunnen relevante parameters worden vergeleken voor verdere analyse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After last visit of last subject.
    Na de laatste fase van de laatste patiënt
    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 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) 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
    na laatste fase van de laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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
    geen
    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 Decision2013-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-11
    P. End of Trial
    P.End of Trial StatusOngoing
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