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    Summary
    EudraCT Number:2012-003090-26
    Sponsor's Protocol Code Number:110401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2012-003090-26
    A.3Full title of the trial
    STUDY TO EVALUATE THE PROPORTIONALITY OF 3 ORAL DOSES OF PIRLINDOLE IN HEALTHY VOLUNTEERS.
    Estudio para evaluar la proporcionalidad de 3 dosis de pirlindol administrado por vía oral en voluntarios sanos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO EVALUATE THE PROPORTIONALITY OF 3 ORAL DOSES OF PIRLINDOLE IN HEALTHY VOLUNTEERS.
    Estudio para evaluar la proporcionalidad de 3 dosis de pirlindol administrado por vía oral en voluntarios sanos.
    A.4.1Sponsor's protocol code number110401
    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 SponsorTECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.
    B.1.3.4CountryPortugal
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.
    B.4.2CountryPortugal
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTECNIMEDE ? SOCIEDADE TÉCNICO MEDICINAL S.A.
    B.5.2Functional name of contact pointSusana Almeida
    B.5.3 Address:
    B.5.3.1Street AddressZona Industrial da Abrunheira, Rua da Tapada Grande nº 2, Abrunheira
    B.5.3.2Town/ citySintra
    B.5.3.3Post code2710-089
    B.5.3.4CountryPortugal
    B.5.4Telephone number351210414 187
    B.5.6E-maildmed.ct@tecnimede.pt
    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 Implementor
    D.2.1.1.2Name of the Marketing Authorisation holderTECNIMEDE SOCIEDADE TÉCNICO MEDICINAL S.A.
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 namePirlindol
    D.3.4Pharmaceutical form 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 INNPIRLINDOLE
    D.3.9.1CAS number 60762-57-4
    D.3.9.3Other descriptive namePIRLINDOLE
    D.3.9.4EV Substance CodeSUB09923MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Not applicable (including healthy volunteers).
    No procede (inclusión de voluntarios sanos).
    E.1.1.1Medical condition in easily understood language
    Not applicable (including healthy volunteers).
    No procede (inclusión de voluntarios sanos).
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    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
    Main objective is to assess the proportionality of 3 pirlindole doses (50, 100 and 150 mg) administered orally in healthy volunteers.
    Como objetivo principal se plantea evaluar la proporcionalidad de 3 dosis de pirlindol (50, 100
    y 150 mg) administradas por vía oral en voluntarios sanos.
    E.2.2Secondary objectives of the trial
    A secondary objective is to evaluate the safety of 3 pirlindole doses administered in healthy volunteers.
    Como objetivo secundario se evaluará la seguridad de las 3 dosis de pirlindol administradas en
    voluntarios sanos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Subjects of either gender (male or female), with an age between 18 and 45 years.
    2.- Body weight within the normal range (Quetelet index between 18 and 29, expressed as
    weight (kg) / height (m2).
    3.- Medical history, physical examination by organs, both within normal limits.
    4.- No evidence of significant disease (organic or psychiatric) based on the anamnesis taking,
    physical examination and complementary tests.
    5.- Laboratory tests (complete blood count and chemistry) within the normal range,
    according to the normal reference values of the chemistry laboratory of the Hospital de la
    Santa Creu i Sant Pau. Variations may be admitted, in accordance with the CIM?s clinical
    criterion.
    6.- Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and ECG
    record within normal range.
    7.- Participating female volunteers must use contraceptive measures other than oral
    contraceptives.
    8.- To have granted consent to participating in the study, with a written informed consent
    signed by the volunteer prior to inclusion in the study.
    1- Sujetos de ambos sexos (masculino o femenino), con una edad entre 18 y 45 años.
    2- peso corporal dentro del rango normal (indice Quetelet entre 18 y 29, expresado como peso (kg) / altura (m).
    3- historia medica, examen físico por organos, ambos dentro limites normales.
    4- Sin evidencia de enfermedades significativas (organica o psiquiatrica) basada en la anamnesis, examen físico y test complementarios.
    5- examenes de laboratorio (contaje y quimica sanguinea) en rango normal de acuerdo con los valores del laboratorio del Hospital de la
    Santa Creu i Sant Pau. Se permitiran variacines de acuerdo con los criterios clínicos del CIM.
    6- Signos vitales (presión sanguinea diastolica y sistolica, frecuancia cardiaca, temperatura) y ECG dentro del rango normal.
    7- Participantes femeninas deben utilizar otras medidas anticonceptivas diferentes a los anticonceptivos orales.
    8-Haber firmado el consentimiento informado antes de la inclusión en el estudio.
    E.4Principal exclusion criteria
    1.- History of allergy, idiosyncrasy or hypersensitivity to drugs.
    2.- Heavy consumer of stimulating drinks (> 5 cups of coffee, tea, chocolate or cola drinks
    per day).
    3.- Prior history of alcohol consumption or use or abuse of recreational drugs.
    4.- Use of any medications within 2 weeks prior to taking the study treatment (except for the
    use of acetaminophen in short-term symptomatic treatments), including over-the-counter
    medications and medicinal plants.
    5.- Positive serology for hepatitis B, C, or for the HIV virus.
    6.- A history or clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine,
    gastrointestinal, haematological, neurological disease, or other chronic diseases.
    7.- To have undergone surgery during the previous 6 months.
    8.- Smokers.
    9.- Pregnancy or breast-feeding.
    10.- To have participated in another clinical trial during the three months prior to starting the current trial.
    11.- To have donated blood in the 4 weeks prior to starting the study.
    1.- Historia de alergia, idiosincrasia o hipersensibilidad a las drogas.
    2.- consumidores asiduos de bebidas estimulantes (> 5 tazas de café, té, chocolate o cola por día).
    3.- historia previa de consumo de alcohol o uso o abuso de drogas recracionales.
    4.- uso de cualquier medicación dentro de las 2 semanas anteriores a la toma de medicación del estudio.
    5.- Serología positiva para hepatitis B, C, o para HIV.
    6.- historia, o evidencia clínica de enfermedad cardiovascular, respiratoria, renal hepatica, endocrina, gastrointestinal, hematologica, neurologica, o otra enfermedad cronica.
    7.- Haber recibido cirugía durante los 6 mese previos.
    8.- Fumadores.
    9.- Embarazadas o madres en periodo de lactancia.
    10.- Haber participato en otro ensayo clínico durante los 3 mese previos al inicio de este ensayo.
    11.- Haber donado sangre en las 4 semanas previas al inicio del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary pharmacokinetic parameters will be obtained after a non-compartmental approach:
    AUC0 t , AUC0? and Cmax of pirlindole, after oral administration of 3 doses evaluated (50, 100
    and 150 mg). These parameters will be used to assess the linearity of the 3 administered doses
    from the power model described by Hummel et al. (Hummel, McKendrick et al. 2009).
    El parámetro farmacocinético primario se obtendra luego de una aproxcimación No-Compartimental: AUC0t, AUC0? y Cmax de pirlindol, luego de administración oral de 3 dosis (50, 100 y 150 mg). Estos parametros serán usados para comprobar linearidad de las 3 dosis administradas
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken (10 ml) at the following times: baseline (pre-dose), + 10 '+ 20' + 30'
    + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dose (total
    15 points extraction).
    Las muestras sanguineas serán tomadas (10 ml) en los tiempos siguientes: pre-dosis, + 10 '+ 20' + 30'
    + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dosis (total de 15 extracciones)
    E.5.2Secondary end point(s)
    Secondary endpoints are: tmax, t1/2, CL/F and V/F of pirlindole after administration of the 3 doses
    evaluated.
    It will also assess the safety of 3 doses of pirlindole by adverse effects, vital signs (SBP / DBP
    and HR) and laboratory parameters.
    Endpoint secundarios son. tmax, t1/2, CL/F y V/F de pirlindol luego de la administración de 3 dosis evaluadas.
    También se evaluará la seguridad de las 3 dosis de pirlindol por aparicióne de efectos adversos, signos vitales, y parametros de laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples will be taken (10 ml) at the following times: baseline (pre-dose), + 10 '+ 20' + 30'
    + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dose (total
    15 points extraction).
    muestras sanguineas serán tomadas (10 ml) en los tiempos siguientes: pre-dosis, + 10 '+ 20' + 30'
    + 45' + 1h, + 1h15 ', + 1h30', 1h45 ',+ 2h, + 3h, 5h +, + 6h, +8 h, +12 h and +24 h post-dosis (total de 15 extracciones)
    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 Yes
    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 No
    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 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 No
    E.8.2.4Number of treatment arms in the trial3
    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
    The clinical trial can be interrupted at the discretion of the principal investigator or Tecnimede, S.A.
    in any of these cases:
    - Occurrence of an unknown adverse event, or known adverse events but with unexpected
    seriousness, duration or incidence.
    - Insufficient number of volunteers included in the study.
    - Cancellation of drug development.
    el ensayo clínico será interrumpido a discreción del investigador principal o Tecnimede, S.A. en cualquiera de estos casos:
    -Evento adverso desconocido, o conocido pero inesperadamente serio, en duración o incidencia.
    -Número insuficiente de voluntarios incluidos en el estudio.
    -Cancelación del envío del medicamento.
    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 months1
    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: 18
    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 state18
    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)
    A physical examination, laboratory safety test (haemathology and biochemistry) and an ECG will be carried out at the end of the study.
    Un examen físico, y pruebas de laboratorio (hematología y bioquímica) y un ECG será realizado al final del estudio
    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 Decision2013-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
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