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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-003814-37
    Sponsor's Protocol Code Number:AKF-400
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-08-18
    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 number2021-003814-37
    A.3Full title of the trial
    The effect of dicloxacillin on oral absorption of drugs
    Dicloxacillins effekt på optagelsen af lægemidler fra tarmen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dicloxacillins effect on the oral absorption of drugs from the intestine
    Dicloxacillins effekt på optagelsen af lægemidler fra tarmen
    A.4.1Sponsor's protocol code numberAKF-400
    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 SponsorOdense University Hosipital
    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 supportThe Novo Nordisk Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Faculty of Health Sciences, University of SOuthern Denmark
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Pharmacology, Pharmacy and Environmental Medicine, Institure of Publich Health, University of Southern Denmark
    B.5.2Functional name of contact pointClinical Pharmacology and Pharmacy
    B.5.3 Address:
    B.5.3.1Street AddressJ.B. Winsløws Vej 19, 2. floor
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4565502352
    B.5.6E-maildbiversen@health.sdu.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 Dicillin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Capsule, hard
    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 INNDICLOXACILLIN
    D.3.9.1CAS number 3116-76-5
    D.3.9.4EV Substance CodeSUB07099MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Healthy volunteers. (Dicloxacillin is used against infections caused by beta-lactamase-producing organisms)
    Testing for drug-drug interactions caused by dicloxacillin.
    Raske frivillige. (Dicloxacillin bruges mod infektioner forårsaget af beta-laktamase producerende organismer).
    Tester for lægemiddelinteraktioner forårsaget af dicloxacillin.
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers.
    (Dicloxacillin is used against bacterial infections)
    Investigating if dicloxacillin causes drug-drug interactions when it is administered for a longer period of time.
    Raske frivillige.

    (Dicloxacillin bruges mod bakterielle infektioner)
    Tester for om dicloxacillin forårsager lægemiddelinteraktioner når det gives i en længere periode.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004035
    E.1.2Term Bacterial infection due to staphylococcus aureus
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary aim of this study is to investigate if treatment with dicloxacillin can lead to drug-drug interactions through induction of the efflux transporter P-glycoprotein (P-gp).
    Hovedformålet med studiet er at undersøge om behandling med dicloxacillin fører til lægemiddelinteraktioner gennem induktion af efflux transporteren P-glycoprotein (P-gp).
    E.2.2Secondary objectives of the trial
    It will be investigated whether or not dicloxacillin induces its own metabolism.
    Det vil blive undersøgt om dicloxacillin inducerer sin egen metabolisme.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18-55 years
    - The following data must be in the normal range or only clinical insignificantly different from this: eGFR, ALAT, bilirubin, HbA1c, hemoglobin
    - BMI >18.5 and < 30 kg/m2
    - Bodyweight ≥ 50 kg
    - Non-smoker (abstained from smoking minimum 2 weeks before the first study day and during the trial)
    - Generally healthy
    - Willing to give informed consent
    - Alder 18-55 år
    - Nyrefunktion (eGFR), leverfunktion (ALAT, bilirubin), langtidsblodsukker (HbA1c) og blodmængde (hæmoglobin) i det normale interval eller uden væsentlig klinisk afvigelse herfra
    - Body Mass Index (BMI) >18,5 og < 30 kg/m
    - Ikke-ryger (har ikke røget i minimum 14 dage inden første forsøgsdag og gennem hele forsøgsperioden)
    - Godt helbred
    - Kropsvægt ≥ 50 kg
    - Villig til at afgive informeret samtykke
    E.4Principal exclusion criteria
    - Known sensitivity to any of the used drugs or any excipients listed in section 6.1 in the Summary of Product Characteristics (SmPC).
    - Intake of any significant prescription drugs, over-the-counter drugs, herbal drugs, or dietary supplements*.
    Contraindicated drugs include:
    Anticoagulants, antiplatelet aggregation medicinal products, ticagrelor, clopidogrel, acetylsalicylic acid, chronic NSAIDs use, amiodarone, verapamil, systemic ketoconazole, clarithromycin, cyclosporin, itraconazole, tacrolimus, posaconazole, dronedarone, glecaprevir/pibrentasvir, quinidine, ritonavir, digoxin, selective serotonin reuptake inhibitors (SSRIs), selective serotonin norephinephrine reuptake inhibitors (SNRIs), pantoprazole, ranitidine, previous use of dicloxacillin or other P-gp or CYP450 inhibitors/inducers within 4 weeks prior to the start of treatment, probenecid, tetracycline, methotrexate
    - Alcohol abuse or if the Danish Health Authority recommendation regarding alcohol intake has been exceeded 2 weeks before the first study day (men 14 units alcohol/week, women 7 unites alcohol/week)
    - Participating in any other intervention trials
    - A positive pregnancy test at inclusion screening or any of the study days
    - Known penicillin allergy or reactions against cephalosporins, cephamycin, 1-oxa-ß-lactamer, or carbapenems
    - Women who are breastfeeding
    - Diagnosis of any of the following diseases (current or previous):
    Mechanical heart valve, congenital or acquired coagulation disorders, thrombocytopenia or functional platelet defects, biopsy within 4 weeks, major trauma, bacterial endocarditis, esophagitis, gastritis, gastroesophageal reflux, active meningitis, encephalitis, intracranial abscess, undergoing surgery, liver disease, history of thrombosis or diagnosed with antiphospholipid syndrome, active cancer
    - Kendt overfølsomhed over for de anvendte lægemidler eller nogle af de hjælpestoffer, der er nævnt i produktresumeet sektion 6.1 for lægemidlerne
    - Indtag af receptlægemidler, håndkøbslægemidler, naturlægemidler eller kosttilskud, der kan ændre effekten af lægemidler anvendt i forsøget*.
    Kontraindicerede lægemidler inkluderer:
    Antikoagulantia, blodpladehæmmende lægemidler, ticagrelor, clopidogrel, acetylsalicylsyre, kronisk anvendelse af NSAID’er, amiodaron, verapamil, quinidin, systemisk ketoconazol, clarithromycin, cyclosporin, itraconazol, tacrolimus, posaconazol, dronedaron, glecaprevir/pibrentasvir, ritonavir, digoxin, selektive serotonin-genoptagshæmmere (SSRI), selektive serotonin norephinephrine-genoptagshæmmere (SNRI), pantoprazol, ranitidin, probenicid, tetracyclin, methotrexat, tidligere brug af dicloxacillin eller andre P-gp eller CYP450 hæmmere/inducere indenfor de sidste 4 uger før forsøgsstart
    - Alkoholmisbrug eller hvis sundhedsmyndighedernes anbefalinger overskrides 14 dage inden forsøgsdagene (mænd 14 genstande/uge, kvinder 7 genstande/uge)
    - Deltagelse i et andet interventionsstudie
    - Positiv graviditetstest inden forsøgets start eller på de pågældende forsøgsdage
    - Kendt penicillin allergi eller overfølsomhed overfor cephalosporiner, cephamycin, 1-oxa-ß-lactamer eller carbapenemer
    - Kvinder der ammer
    - Diagnose af en af følgende sygdomme (nuværende eller tidligere): mekanisk hjerteklap, medfødt eller erhvervede koagulationsforstyrrelser, trombocytopeni eller blodpladefejl, biopsi 4 uger inden forsøgsstart, større traumer, bakteriel endokarditis, esophagitis, gastritis, gastroesophagael reflux, aktiv menigitis, encephalitis, intrakraniel abscess, gennemgår operation, leversygdom, fortid med blodprop eller diagnosticeret med antiphospholipidsyndrom, aktiv kræft
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in AUC of the P-gp substrate dabigatran after 28 days of dicloxacillin treatment compared to baseline.
    Det primære endepunkt er ændring i AUC for P-gp substratet dabigatran efter 28 dages behandling med dicloxacillin sammenlignet med baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the drug analysis is completed
    Nå lægemiddelanalysen er afsluttet
    E.5.2Secondary end point(s)
    Changes in the full pharmacokinetics of the P-gp substrate dabigatran etexilate and all relevant metabolites after 10 and 28 days of dicloxacillin treatment compared to baseline. The concentrations will be determined from plasma and urine samples.

    Changes in the full pharmacokinetics of dicloxacillin and its metabolites after 9 and 27 days of dicloxacillin treatment compared to baseline. This will be measured as concentrations in plasma and urine samples.

    Changes in biomarkers of DMET after 10 and 28 days of dicloxacillin treatment compared to baseline.

    Changes in exosome-derived biomarkers after 10 and 28 days of dicloxacillin treatment compared to baseline.
    Ændringer i farmakokinetikken for P-gp substratet dabigatran etexilate og alle dets relevante metabolitter efter 10 og 28 dages dicloxacillin behandling sammenlignet med baseline. Koncentrationen bliver målt i plasma og urinprøver.

    Ændringer i farmakokinetikken af dicloxacillin og dets metabolitter efter 9 og 27 dages behandling med dicloxacillin sammenlignet med baseline. Koncentrationen bliver målt i plasma og urinprøver.

    Ændring i biomarkører for DMET efter 10 of 28 dages dicloxacillin behandling sammenlignet med baseline.

    Ændring i exosome-biomarkører efter 10 og 28 dages behandling med dicloxacillin sammenlignet med baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the drug analysis is completed
    Når lægemiddelanalysen er afsluttet
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic trial
    Farmakokinetisk forsøg
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Selv-kontrolleret
    Self-controlled
    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 is defined as the day for the phone call 2 weeks after the last visit from the last trial subject.
    LVLS.
    LVLS er defineret som dagen for opringningen, 2 uger efter det sidste besøg fra den sidste forsøgsdeltager.
    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 months3
    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: 12
    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 state12
    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)
    In 3 weeks after the last visit the subjects need to use the following contraceptives to be sure of optimal protection, condom and/or diaphragm with spermicide or intrauterine device (copper or hormone).
    Subjects will be contacted 2 weeks after the last visit and asked about any potential adverse events.
    I 3 uger efter sidste besøg skal forsøgsdeltagerne benytte sig af følgende prævention for at være sikker på at opnå optimal beskyttelse, spiral (kobber- eller hormonspiral) eller kondom og/eller pessar med sæddræbende creme.
    Forsøgsdeltagere vil desuden blive kontaktet 2 uger efter det sidste besøg og blive spurgt ind til om de har oplevet nogle bivirkninger.
    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 Decision2021-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-06-21
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