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    The EU Clinical Trials Register currently displays   44235   clinical trials with a EudraCT protocol, of which   7336   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-002836-26
    Sponsor's Protocol Code Number:DDD13POSA
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-002836-26
    A.3Full title of the trial
    Gastrointestinal behavior of posaconazol in healthy human volunteers
    Gastrointestinaal gedrag van posaconazol in gezonde vrijwilligers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gastrointestinal behavior of posaconazol in healthy human volunteers
    Gastrointestinaal gedrag van posaconazol in gezonde vrijwilligers
    A.3.2Name or abbreviated title of the trial where available
    Gastrointestinal behavior of posaconazol in healthy human volunteers
    Gastrointestinaal gedrag van posaconazol in gezonde vrijwilligers
    A.4.1Sponsor's protocol code numberDDD13POSA
    A.5.4Other Identifiers
    Name:Clinical Trial Center UZ LeuvenNumber:S
    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 SponsorKU Leuven - Drug Delivery & Disposition
    B.1.3.4CountryBelgium
    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 supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointDrug Delivery & Disposition
    B.5.3 Address:
    B.5.3.1Street AddressGasthuisberg ON2 - Herestraat 49 box 921
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number3216330302
    B.5.5Fax number3216330305
    B.5.6E-mailbart.hens@pharm.kuleuven.be
    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 Posaconazol 40mg/mL Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderSchering-Plough
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameNoxafil
    D.3.4Pharmaceutical form Suspension for use in drinking water
    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
    Suspension: 105 mg posaconazol (2.6 ml Noxafil): 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water.

    Solution: 105 mg dissolved posaconazol (via Noxafil) by acidification of HCl until pH 1.2: 1)with 250 ml water 2)with 250 ml sparkling water 3)with 5 lumps of sugar, dissolved in 250 ml water 3)with 5 lumps of sugar, dissolved in 250 ml of sparkling water.
    Suspensie: 105 mg posaconazol (via 2.6 ml Noxafil): 1)met 250 ml water 2)met 250 ml spuitwater 3)met 250 ml water, waarin 5 klontjes suiker zijn opgelost 4)met 250 ml spuitwater, waarin 5 klontjes suiker zijn opgelost.

    Oplossing: 105 mg opgelost posaconazol (via 2.6 ml Noxafil) door aan te zuren met HCl tot pH 1.2: 1)in 250 ml water. 2)in 250 ml spuitwater 3)in 250 ml water, waarin 5 klontjes suiker zijn opgelost. 4)in 250 ml spuitwater, waarin 5 klontjes suiker zijn opgelost.
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (18-40 years)
    Gezonde vrijwilligers (18-40 jaar)
    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
    Study of the gastrointestinal behavior of posaconazol in healthy volunteers by using a suspension of the drug and a solution. This will learn us more about the behaviour of the drug in the GI tract (supersaturation/ precipitation/ dissolution/ ...)
    Studie van het gastrointestinaal gedrag van posaconazol in gezonde vrijwilligers door gebruik te maken van enerzijds een suspensie en anderzijds een oplossing. Dit zal leiden tot meer inzicht in het GI gedrag van posaconazol (optreden van supersaturatie/ precipitatie/ in oplossing gaan/ ...)
    E.2.2Secondary objectives of the trial
    1)To see any difference between administration of a suspension of the drug versus a solution (differences to supersaturation potential, precipitation potential and absorption potential)
    2)To see any difference of supersaturation, precipitation or absorption between the 2 formulations, when there is another time of gastric emptying (induced by the lumps of sugar/ sparkling water)
    1)Nagaan of er een verschil is in intestinaal gedrag wanneer een oplossing van het geneesmiddel wordt gegeven versus de suspensie van het geneesmiddel (verschillen naar supersaturatie, precipitatie en absorptie)
    2)Evalueren of er een invloed is op supersaturatie, precipitatie of absorptie door in te spelen op de snelheid van maaglediging (beïnvloed door de klontjes suiker, het spuitwater)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Healthy volunteers
    -age between 18 and 40 years old
    -Gezonde vrijwilligers
    -Leeftijd tussen de 18 en 40 jaar
    E.4Principal exclusion criteria
    -pregnancy
    -disease
    -use of medication
    -zwangerschap
    -ziekte
    -gebruik van medicatie
    E.5 End points
    E.5.1Primary end point(s)
    Not applicable
    Niet toepasbaar
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet toepasbaar
    E.5.2Secondary end point(s)
    Not applicable
    Niet toepasbaar
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet toepasbaar
    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 Yes
    E.8.1.1Randomised No
    E.8.1.2Open No
    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
    Evaluatie van het gastrointestinaal gedrag van posaconazol in 8 verschillende condities
    Evaluation of the gastrointestinal behavior of posaconazol in 8 different conditions
    E.8.2.4Number of treatment arms in the trial8
    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
    last visit of last subject
    laatste bezoek van laatste vrijwilliger
    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 months6
    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 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 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)
    Not applicable
    Niet van toepassing
    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 Decision2013-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-10
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