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    Summary
    EudraCT Number:2020-004044-28
    Sponsor's Protocol Code Number:AKF-396
    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:2020-10-27
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2020-004044-28
    A.3Full title of the trial
    Flucloxacillin as an inducer of CYP-enzymes
    Kan flucloxacillin påvirke andre lægemidlers effekt?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can flucloxacillin affect other drugs effect?
    Kan flucloxacillin påvirke andre lægemidlers effekt?
    A.4.1Sponsor's protocol code numberAKF-396
    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 Southern Denmark
    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, Institute of Public 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
    B.5.3.2Town/ cityOdense
    B.5.3.3Post code5000
    B.5.3.4CountryDenmark
    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 Flucloxacillin
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Corporation
    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 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 INNFLUCLOXACILLIN
    D.3.9.1CAS number 5250-39-5
    D.3.9.4EV Substance CodeSUB07673MIG
    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.
    (Flucloxacillin is used against infections caused by beta-lactamase-producing organisms)
    Testing for drug-drug interactions caused by flucloxacillin
    Raske frivillige

    (Flucloxacillin bruges mod infektioner forårsaget af beta-laktamase producerende organismer)
    Tester for lægemiddelinteraktioner forårsaget af flucloxacillin
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers.

    (Flucloxacillin is used against bacterial infections)

    Investigating if flucloxacillin causes drug-drug interactions when it is administered for a longer period of time
    Raske frivillige.

    (Flucloxacillin bruges mod bakterielle infektioner)

    Tester for om flucloxacillin 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 aim of this study is to investigate if treatment with flucloxacillin increases drug metabolism in healthy volunteers, through induction of cytochrome P450 (CYP) enzymes, CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4.
    Hovedformålet med studiet er at undersøge om behandling med flucloxacillin fører til en stigning i lægemiddelmetabolismen i raske frivillige, via induktion af cytokrom P450 (CYP) CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6 and CYP3A4
    E.2.2Secondary objectives of the trial
    It will be investigated whether or not flucloxacillin induces its own metabolism.
    Det vil blive undersøgt om flucloxacillin inducerer sin egen metabolisme.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is NO sub-study, however, the page indicates errors when choosing "No" in E.2.3
    Der er intet sub-studie. Hjemmesiden skrev der var fejl når svarmuligheden "No", E.2.3 blev valgt.
    E.3Principal inclusion criteria
    - Age 18-55 years
    - The following data have to be in the normal range or only clinical insignificantly different from this: eGFR, ALAT, bilirubin, HbA1c, haemoglobin
    - BMI 18.5 – 29.9 kg m-2
    - Non-smoker (abstained from smoking minimum 2 weeks before the first study day and during the trial)
    - Generally healthy
    - Willing to give informed consent
    - 18-55 år
    - Nyrefunktion (eGFR), leverfunktion (ALAT, bilirubin), glykeret hæmoglobinniveau (HbA1c) og hæmoglobin værdier i det normale interval eller uden væsentlig klinisk afvigelse herfra
    - BMI 18,5 – 29,9 kg m-2
    - Ikke-ryger (Har ikke røget minimum 2 uger inden første forsøgsdag og gennem hele forsøgsperioden)
    - Godt helbred
    - 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)
    - Known allergy towards penicillin or cephalosporines
    - Any of the following diseases (current or previous): Heart disease, known family history of prolonged QTc interval, sudden death or conditions that might prolonged QTc-intervals, hypotension, severe disturbance of electrolyte balance e.g. hypokalemia or hypomagnesemia, myasthenia gravis, lung- or respiratory diseases, an anatomically abnormality of the respiratory tract, sleep apnea syndrome
    - Intake of any significant prescription drugs, over-the-counter drugs, herbal drugs or dietary supplements. Contraindicated drugs include: Benzodiazepines, beta blockers, ergot alkaloids, herbal preparations containing St. John’s wort, antiarrhythmics, neuroleptics, antidepressive agents, antibiotics, antifungal agents, non- sedating antihistamines, antimalarials, methadone, elbasvir, grazoprevir, nelfinavir cisapride, pimozide, bepridil
    - 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 units alcohol/week)
    - Women who are breastfeeding
    - Positive pregnancy test at inclusion screening or at any of the study days
    - Participation in any other interventional trials
    - Tidligere kendt overfølsomhed over for de anvendte stoffer eller hjælpestoffer, der er listet i sektion 6.1 i produktresumeet.
    - En af følgende sygdomme (nuværende eller tidligere diagnosticeret): Hjertesygdom, familie historie med forlænget QTc interval eller lidelser der kan forårsage dette, eller pludselig død i familien, hypotension, alvorlige forstyrrelse af elektrolytbalancen, f.eks. hypokalæmi eller hypomagnesæmi, myasthenia gravis, lunge- eller respiratorisk sygdom, en anatomisk abnormitet i luftvejene, søvnapnø.
    - Indtag af receptlægemidler, håndkøbslægemidler, naturlægemidler eller kosttilskud, der kan interagere med lægemidlerne anvendt i forsøget. Kontraindicerede lægemidler inkluderer: Benzodiazepiner, betablokkere, ergot alkaloider, naturmedicin indeholdende St. John's wort, antiarytmika, neuroleptika, antidepressiva, antibiotika, svampemidler, non-sederende antihistaminer, antimalaria, metadon, elbasvir, grazoprevir, nelfinavir, cisapride, pimozide, bepridil.
    - 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 ved inklusionsscreening eller på de pågældende forsøgsdage
    - Kendt allergi overfor penicilliner eller cefalosporiner
    - Kvinder der ammer
    -
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change in AUC of the CYP3A4 substrate midazolam, after 28 days of flucloxacillin treatment compared to baseline.
    Det primære endepunkt er ændring i AUC for CYP3A4 substratet midazolam efter 28 dages behandling med flucloxacillin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the study is completed and drug analysis is completed.
    Når studiet er afsluttet og lægemiddelanalysen er afsluttet.
    E.5.2Secondary end point(s)
    Changes in the pharmacokinetics of the six substrates midazolam (substrate of CYP3A4), caffeine (CYP1A2), efavirenz (CYP2B6), losartan (CYP2C9), omeprazole (CYP2C19) and metoprolol (CYP2D6) and their metabolites after 10 and 28 days of flucloxacillin treatment compared to baseline. The concentrations will be determined from plasma and urine samples.

    Changes in the full pharmacokinetics of flucloxacillin and its metabolite after 9 and 27 days of flucloxacillin treatment compared to baseline. This will be measured as concentrations in plasma and urine samples.
    Ændringer i AUC for de seks substrater midazolam (substrat til CYP3A4), koffein (CYP1A2), efavirenz (CYP2B6), losartan (CYP2C9), omeprazole (CYP2C19) og metoprolol (CYP2D6) og deres metabolitter efter 10 og 28 dages behandling med flucloxacillin, sammenlignet med baseline. Dette vil blive målt som koncentrationen i plasma og urin prøver.

    Ændring i AUC for flucloxacillin, før og efter 9 og 27 dages behandling med flucloxacillin. Dette vil blive målt som koncentrationen af flucloxacillin og dens metabolit i plasma og urin prøver.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the study is completed and drug analysis is completed.
    Når studiet er afsluttet og 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
    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 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: 14
    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 state14
    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 6 weeks after the last visit the subjects needs 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 effects.
    I 6 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 oplever 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 Decision2020-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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