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    Summary
    EudraCT Number:2015-003940-38
    Sponsor's Protocol Code Number:POPK-1501
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-003940-38
    A.3Full title of the trial
    Plasma level pharmacokinetics study of posaconazole with the sequential use of two oral formulations (oral suspension and solid tablets) in haematology patients with a high risk of invasive mycoses.
    Estudio secuencial de farmacocinética a nivel plasmático con dos formulaciones orales de posaconazol (suspensión oral y comprimidos gastrorresistentes) en pacientes hematológicos con riesgo elevado de contraer micosis invasoras.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of posaconazole blood levels comparing two different oral presentations, a syrup and a solid tablet, in patients with leukaemia at a high risk of fungal infections
    Estudio de niveles de posaconazol en sangre comparando dos presentaciones del fármaco, una en jarabe y otra en tabletas, en pacientes con leucemia con alto riesgo de infecciones fúngicas
    A.4.1Sponsor's protocol code numberPOPK-1501
    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 SponsorFundación Investigación Biomédica Puerta de Hierro
    B.1.3.4CountrySpain
    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 supportMerck Sharp & Dohme España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Investigación Biomédica Puerta de Hierro
    B.5.2Functional name of contact pointDr. Rafael F. Duarte
    B.5.3 Address:
    B.5.3.1Street AddressCalle Joaquín Rodrigo 2
    B.5.3.2Town/ cityMajadahonda
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number34911916303
    B.5.6E-mailrduarte.work@gmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Noxafil 40 mg/ml suspensión oral
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire; EN11 9BU UK
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Oral suspension
    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 INNPOSACONAZOLE
    D.3.9.1CAS number 171228-49-2
    D.3.9.2Current sponsor codePOSACONAZOLE
    D.3.9.3Other descriptive namePOSACONAZOLE
    D.3.9.4EV Substance CodeSUB20322
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.IMP: 2
    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 Noxafil 100 mg comprimidos gastrorresistentes
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Ltd. Hertford Road, Hoddesdon Hertfordshire; EN11 9BU, UK
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Gastro-resistant 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 INNPOSACONAZOLE
    D.3.9.1CAS number 171228-49-2
    D.3.9.2Current sponsor codePOSACONAZOLE
    D.3.9.3Other descriptive namePOSACONAZOLE
    D.3.9.4EV Substance CodeSUB20322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Invasive Mycoses
    Micosis invasoras
    E.1.1.1Medical condition in easily understood language
    Severe fungal infections
    Infecciones graves por hongos
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    The main objective of this trial is to describe and compare the plasma-level pharmacokinetic profile of two oral formulations of posaconazole, oral suspension and solid tablets, administered sequentially to the same subjects
    El objetivo principal de este estudio es describir el perfil farmacocinético del posaconazol a nivel plasmático de manera comparada entre la suspensión oral y los comprimidos gastrorresistentes, administradas de manera secuencial en los mismos sujetos.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate the gastrointestinal tolerability and treatment experience with both formulations for the patient, to evaluate laboratory safety results and to describe any potential episodes of breakthrough invasive mycosis that may occur during the study treatment.
    Los objetivos secundarios del estudio son evaluar la tolerabilidad gastrointestinal y experiencia de tratamiento para el paciente con ambas formulaciones, evaluar los resultados de seguridad de laboratorio, así como registrar cualquier episodio potencial de micosis invasora que pudiese ocurrir durante el tratamiento de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patiens with an indication for antifungal prophylaxis with posaconazole for prolonged severe neutropenia after intensive chemotherapy for acute myeloid leukemia or myelodysplastic syndromes.
    Pacientes adultos con indicación de profilaxis antifúngica con posaconazol por neutropenia grave prolongada por quimioterapia intensiva para leucemia aguda mieloblástica o síndromes mielodisplásicos.
    E.4Principal exclusion criteria
    Excluded are patients with a history of invasive mycosis, recipients of allogeneic transplantation with or without graft-versus-host disease, with abnormal liver or renal function, prolonged QTc, ECOG >2, pregnant women, or those with some concomitant or previous treatments.
    Se excluyen pacientes con antecedentes de micosis invasora, receptores de trasplante alogénico con o sin enfermedad injerto contra receptor, con alteraciones de función hepática o renal, QTc alargado, con ECOG >2, embarazadas, o con determinados tratamientos previos o concomitantes
    E.5 End points
    E.5.1Primary end point(s)
    Primary objective of the study is to compare the pharmacokinetic profile of posaconazole oral suspension and solid tablets when administered sequentially to the same subjects.

    The pharmacokinetic variables are:
    - Cmin: Minimal concentration
    - Cmax: Maximal observed concentration
    - Tmax: Time to Cmax
    - AUC: Area under the concentration/time curve
    - Cavg: AUC/dose interval
    El objetivo principal de este estudio es describir el perfil farmacocinético del posaconazol a nivel plasmático de manera comparada entre la solución oral y los comprimidos gastrorresistentes al administrar ambas formulaciones de manera secuencial en los mismos sujetos.

    Las variables farmacocinéticas de valoración son:
    - Cmin: Concentración mínima
    - Cmax: Concentración máxima observada
    - Tmax: Tiempo hasta Cmax
    - AUC: Área bajo la curva de concentración/tiempo
    - Cpro: AUC/intervalo de dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic samples will be taken:
    - Day 1 and 8 of treatment with both formulations on time 0, +2h, +8h, +24h.
    - End of treatment, a trough sample before last dose of study treatment.
    Muestras de farmacocinética se obtendrán:
    - Los días 1 y 8 de tratamiento con las dos formulaciones a tiempo 0, +2h, +8h, +24h.
    - Al final de tratamiento, una muestra valle antes de la última dosis de tratamiento de estudio.
    E.5.2Secondary end point(s)
    The secondary objectives are to evaluate gastrointestinal tolerability and treatment experience for the subjects with both formulations, to evaluate laboratory toxicity, to register any potential episodes of breakthrough invasive mycosis during study treatment, and to do a final evaluation of survival after end of treatment.
    Los objetivos secundarios del estudio son evaluar la tolerabilidad gastrointestinal y experiencia de tratamiento para el paciente con ambas formulaciones, evaluar los resultados de seguridad de laboratorio, registrar cualquier episodio potencial de MI que pudiese ocurrir durante el tratamiento de estudio, y hacer una evaluación final de supervivencia tras el fin de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    In every study visit (daily in inpatients) and final evaluation 1 week after end of treatment.
    En cada visita de estudio (diaria en ingresados) y a la evaluación final 1 semana tras el fin de tratamiento.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Otra formulación del mismo fármaco
    Other formulation of the same medicinal product
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    UVUS
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 20
    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 No
    F.3.2Patients Yes
    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 state20
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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