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    Summary
    EudraCT Number:2013-001976-39
    Sponsor's Protocol Code Number:CHDR1227
    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 number2013-001976-39
    A.3Full title of the trial
    Randomized, open-label, crossover study into the contribution of the intestines and kidney in the diurnal variation of Levofloxacin pharmacokinetics
    Een onderzoek naar de dag/nacht ritmes in de opname en afbraak van het antibioticum Levofloxacine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Day/night rhythms in the uptake and elimination of the antibiotic Levofloxacin
    Een onderzoek naar de dag/nacht ritmes in de opname en afbraak van het antibioticum Levofloxacine.
    A.3.2Name or abbreviated title of the trial where available
    Diurnal variation of levofloxacin pharmacokinetics
    Dag/nacht ritme in de farmacokinetiek van Levofloxacine
    A.4.1Sponsor's protocol code numberCHDR1227
    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 SponsorCentre for Human Drug Research
    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 supportStichting Technologie en Wetenschap
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for Human Drug Research
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031715246400
    B.5.5Fax number0031715246499
    B.5.6E-mailclintrials@chdr.nl
    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 Levofloxacine 500 mg, filmomhulde tabletten
    D.2.1.1.2Name of the Marketing Authorisation holderPharmachemie BV
    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
    The circadian variation in the relative contribution of intestinal uptake and renal elimination of levofloxacin
    De dag/nacht ritmes in de opname en afbraak van het antibioticum Levofloxacine.
    E.1.1.1Medical condition in easily understood language
    Day/night rhythm in the uptake and elimination of levofloxacin
    De dag/nacht ritmes in de opname en afbraak van het antibioticum Levofloxacine.
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 evaluate diurnal variation of the pharmacokinetics of Levofloxacin
    Het doel van dit onderzoek is de opname van het antibioticum Levofloxacine in de darmen en de uitscheiding door de nieren in kaart te brengen.
    E.2.2Secondary objectives of the trial
    To explore the daily variation in the magnitude of QT interval prolongation by Levofloxacin
    Het onderzoeken van de dagelijkse variatie van het effect van Levofloxacine op het QT interval.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy male subjects (Caucasians), 18 to 50 years of age, inclusive. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis.
    2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
    3. Regular bedtimes (between 23:00 and 24:00h) and wake-up times (between 07:00 and 08:00) from one week prior to the study.
    4. Ability to communicate well with the investigator in the Dutch language.
    5. Ability to participate and willing to give written informed consent and to comply with the study restrictions.
    1. Mannelijke vrijwilligers tussen de 18 en 50 jaar oud, inclusief;
    2. Body mass index (BMI) tussen 18 en 30 kg/m2, inclusief;
    3. Vermogen en bereidheid om schriftelijk toestemming te geven voor deelname;
    4. Goede gezondheid, gebaseerd op resultaten van medische geschiedenis, lichamelijk onderzoek, vitale functies,
    electrocardiogram (ECG), en laboratorische bloed en urine onderzoek;
    5. Aderen zijn voldoende toegankelijk om bloed af te nemen zoals staat beschreven in het protocol.
    E.4Principal exclusion criteria
    1. History of clinically significant haematologic, renal, hepatic, cardiovascular, neurologic, endocrinal, oncologic, pulmonary, immunologic, or psychiatric disorders;
    2. Positive for hepatitis B, C or Human Immunodeficiency Virus (HIV);
    3. Positive drug screen result (i.e. positive for cocaine, opiates, amphetamine, cannabis and/or benzodiazepines) at screening and before drug administration;
    4. Positive alcohol breath test result at screening or before drug administration;
    5. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg;
    6. Any of the following findings in the resting ECG:
    a. Screening or baseline ECG with QRS and/or T wave judged to be unfavourable for a consistently accurate QT measurement (e.g., neuromuscular artefact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T wave, merged T- and U-waves, prominent U waves);
    b. QTcB> 450 or < 300 msec at screening or baseline visit;
    7. Use of prescription medication within 2 weeks prior to drug administration;
    8. Use of over-the-counter medication (including homeopathic medicines and vitamins) within 3 days prior to Day 1. An exception is paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented by the Investigator.
    9. History of seizures or any disorder that predispose to seizures;
    10. Personal or family history of congenital long QT syndrome or sudden death;
    11. History of clinically significant allergies, including relevant drug hypersensitivity or allergy;
    12. Presence or history of alcoholism or drug abuse;
    13. Use of more than 21 units of alcohol per week;
    14. Use of more than 8 units of caffeine per day;
    15. Smoking (subjects had to be non-smokers for at least 90 days preceding Screening);
    16. Transmeridian flights or shift work within a month prior to the start of the study;
    17. Extreme morning and evening types (determined by the Horne-Ostberg Morningness/Eveningness Questionnaire).
    18. Participation in another clinical trial within 3 months prior to the start of this study or more than 4 times a year;
    19. Loss of blood over 500 mL within 3 months prior to screening;
    20. Unsuitable to participate in the study for any reason in the opinion of the PI.
    1. Geschiedenis van klinisch significante hematologische, renale, hepatische, cardiovasculaire, neurologische, endocriene, oncologische, pulmonaire, immunologische, of psychiatrische aandoeningen;
    2. Positieve test voor hepatitis B, C of Human Immunodeficiency Virus (HIV);
    3. Positieve test voor drugs (d.w.z. positieve test op cocaine, opiaten, amfetamine, cannabis en/of
    benzodiazepines) tijdens de keuring en voor toediening van onderzoeksmedicatie;
    4. Positieve test voor alcohol in adem tijdens de keuring en voor toediening van onderzoeksmedicatie;
    5. Systolische bloeddruk van meer dan 140 of minder dan 90mm Hg, en diastolische bloeddruk van meer dan 90 of minder dan 50 mm Hg;
    6. Een van de volgende uitslagen in een ECG gemeten in rust (tijdens screening of baseline):
    - QRS en/of T wave worden geacht niet te kunnen worden gebruikt om consequent een accurate lengte van het QT interval te berekenen;
    - QTcB>450 of <300msec
    7.Gebruik van voorgeschreven medicatie in de 14 dagen voor toediening van onderzoeksmedicatie;
    8. Gebruik van zelfzorgmedicatie (inclusief homeopatische medicatie en vitamines) in de 3 dagen voor Dag 1. Een uitzondering is paracetamol (max 4g per dag). Andere uitzonderingen worden alleen gemaakt na overleg met, en documentatie door, de PI
    9. Geschiedenis van epileptische aanvallen of aandoeningen die de kans hierop vergroten;
    10. Persoonlijke of familiegeschiedenis van aangeboren lang QT syndroom of plotse hartdood;
    11. Geschiedenis van klinisch significante allergieën, inclusief relevante medicijn overgevoeligheid of allergie;
    12. Thans bekend met of geschiedenis van alcohol of drugsmisbruik;
    13. Gebruik van meer dan 21 eenheden alcohol per week;
    14. Gebruik van meer dan 8 eenheden caffeine per dag;
    15. Roken (deelnemers mogen niet hebben gerookt voor ten minste 90 dagen voorafgaande aan de keuring;
    16. Transmeridiane vluchten of werk in ploegendiensten/nachtdiensten in een maand voor de start van de studie;
    17. Extreme ochtend- of avondmensen (vastgesteld dmv de Horne-Ostberg Morningness/Eveningness Questionnaire;
    18. Deelname aan een ander klinisch onderzoek in de 3 maanden voorafgaand aan studiestart of meer dan 4 keer per jaar;
    19. Bloedverlies van meer dan 500 mL in de 3 maanden voorafgaande aan keuring;
    20. Niet geschikt om deel te nemen aan het onderzoek om welke reden dan ook volgens de onderzoeker.
    E.5 End points
    E.5.1Primary end point(s)
    The main PK parameters (Cmax, Tmax, t1/2, Vd, fu, CL and F) will be determined at each of the 6 experimental time points in order to establish their variation during the 24hr period.
    De volgende farmacokinetische parameters worden bepaald:

    - Cmax, Tmax, halveringstijd, distributievolume en klaring van Levofloxacine

    Voor elke parameter zal het circadiane profiel bepaald worden per vrijwilliger.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Levofloxacin blood samples are taken on each of the six study days at t=0, 30, 60, 90, 120, 150, 180, 240, 300, 360, 480, 600, 720min after administration
    Levofloxacine bloed monsters worden genomen op elke van de zes studiedagen op t=0, 30, 60, 90, 120, 150, 180, 240, 300, 360, 480, 600, 720min na toediening
    E.5.2Secondary end point(s)
    The effect of levofloxacin on QT-interval will be determined at each of the 6 experimental time points in order to establish their variation during the 24hr period.
    Het effect van Levofloxacine op het QT interval wordt bepaald op de 6 toedieningstijden om de variatie hiervan gedurende de dag/nacht
    E.5.2.1Timepoint(s) of evaluation of this end point
    ECGs are recorded at t=0, 30, 60, 90, 120, 150, 180, 240, 360, 480, 720min
    ECGs worden gemaakt op t=0, 30, 60, 90, 120, 150, 180, 240, 360, 480, 720min
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 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
    Toediening op verschillende kloktijden
    Administration at different clock times
    E.8.2.4Number of treatment arms in the trial6
    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 years
    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: 12
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 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)
    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 Opinion2013-07-30
    P. End of Trial
    P.End of Trial StatusOngoing
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