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    Summary
    EudraCT Number:2014-002389-62
    Sponsor's Protocol Code Number:8-55-52030-309
    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:2016-02-17
    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 number2014-002389-62
    A.3Full title of the trial
    Phase IIa, open label, dose ascending study to determine the maximum tolerated dose, safety and tolerability, pharmacokinetics and pharmacodynamics of a single dose of lanreotide PRF in subjects with acromegaly previously treated and controlled with either octreotide LAR or lanreotide Autogel
    Estudio abierto de fase IIa y dosis ascendentes para determinar la dosis máxima tolerada, la seguridad, la tolerabilidad, la farmacocinética y la farmacodinámica de una sola dosis de lanreotida (liberación prolongada) en sujetos con acromegalia ya tratados y controlados con octreotida (acción prolongada) o con lanreotida Autogel.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to determine the maximum dose, safety and tolerability of one injection of lanreotide prolonged release formulation in patients with acromegaly previously treated with either octreotide LAR or lanreotide Autogel
    Un ensayo clínico para determinar la dosis máxima tolerada, la seguridad y la tolerabilidad de una inyección de lanreotida de liberación prolongada en pacientes con acromegalia previamente tratada con octreotida (acción prolongada) o con lanreotida Autogel.
    A.4.1Sponsor's protocol code number8-55-52030-309
    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 SponsorIpsen Group
    B.1.3.4CountryFrance
    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 supportIpsen Group
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIpsen Group
    B.5.2Functional name of contact pointExecutive VP Research & Development
    B.5.3 Address:
    B.5.3.1Street Address65 Quai Georges Gorse
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92650
    B.5.3.4CountryFrance
    B.5.4Telephone number+331 58335000
    B.5.5Fax number+331 58335001
    B.5.6E-mailct-application@ipsen.com
    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 No
    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 nameLanreotide PRF
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeBN 52030, BIM-23014C
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 No
    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 nameLanreotide PRF
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeBN 52030, BIM-23014C
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number270
    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: 3
    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 No
    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 nameLanreotide PRF
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLanreotide acetate
    D.3.9.1CAS number 127984-74-1
    D.3.9.2Current sponsor codeBN 52030, BIM-23014C
    D.3.9.3Other descriptive nameLANREOTIDE ACETATE
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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
    Acromegaly
    Acromegalia
    E.1.1.1Medical condition in easily understood language
    Acromegaly
    Acromegalia
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To identify the maximum tolerated dose (MTD) and to investigate the pharmacokinetics (PK) of a single dose of lanreotide PRF in subjects with acromegaly
    Identificar la dosis máxima tolerada (DMT) e investigar la farmacocinética de una dosis única de lanreotida (liberación prolongada) en sujetos con acromegalia.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of a single dose of lanreotide PRF
    To investigate the pharmacodynamics (PD) of a single dose of lanreotide PRF
    To investigate the PK of the excipient
    Investigar la seguridad y tolerabilidad de una dosis única de lanreotida (liberación prolongada).
    Investigar la farmacodinámica de una dosis única de lanreotida (liberación prolongada).
    Investigar la farmacocinética del excipiente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must fulfil all of the following criteria to be included in the study:
    - Documented diagnosis of acromegaly.
    - Provided written informed consent prior to any study related procedures.
    - Between 18 and 75 years of age inclusive.
    - Female of nonchildbearing potential or male. Nonchildbearing potential is defined as being postmenopausal for at least 1 year, or women with documented infertility (natural or acquired).
    - Male subjects must agree that, if their partner is at risk of becoming pregnant, they will use a medically accepted, effective method of contraception (i.e. condom) for the duration of the study (maximum of 7 months).
    - Treatment with a stable dose of either octreotide LAR or lanreotide Autogel for at least 3 months immediately prior to study entry, with confirmation of disease control during this treatment period (documentation of age adjusted IGF-1 <1.3 x ULN, based on local laboratory results, during the Screening period. Samples for analysis by central laboratory will also be collected during Screening).
    - If the subject is receiving treatment for hypertension, the dose has been stable for at least 1 month prior to study entry.
    - Subjects must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period and willing to return to the clinic for the follow up evaluation as specified in the protocol.
    Los pacientes deberán cumplir todos y cada uno de los siguientes criterios para participar en el estudio:
    - Diagnóstico documentado de acromegalia.
    - Obtención del consentimiento informado por escrito antes de realizar cualquiera de los procedimientos relacionados con el estudio.
    - Edad comprendida entre los 18 y los 75 (inclusive).
    - Hombres o mujeres que no sean fértiles. Se considerará que no son fértiles las mujeres que han sido posmenopáusicas durante al menos 1 año o las que tengan infertilidad confirmada (natural o adquirida).
    - Los pacientes cuyas parejas tengan riesgo de quedarse embarazadas deben comprometerse a usar un método anticonceptivo eficaz y médicamente aceptado (como el preservativo) mientras dure el estudio (un máximo de 7 meses).
    - Tratamiento con una dosis estable de octreotida de acción prolongada o lanreotida Autogel durante por lo menos 3 meses inmediatamente antes de entrar en el estudio, con enfermedad controlada confirmada durante este período de tratamiento (niveles documentados de IGF 1 ajustado por edad <1,3 x LSN, en función de los resultados analíticos locales, durante el período de selección. También se recogerán muestras para análisis en el laboratorio central durante la selección).
    - Si el paciente recibe tratamiento para la hipertensión, la dosis debe haberse mantenido estable durante al menos 1 mes antes de entrar en el estudio.
    E.4Principal exclusion criteria
    Subjects will not be included in the study if the subject:
    - Has undergone radiotherapy within 2 years prior to study entry.
    - Has been treated with a dopamine agonist and/or GH receptor antagonist or has undergone pituitary surgery within 3 months prior to study entry.
    - Is anticipated to require pituitary surgery or radiotherapy during the study.
    - Has clinically significant hepatic abnormalities and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ?3 x ULN and/or alkaline phosphatase (AP) ?2.5 x ULN and/or total bilirubin ?1.5 x ULN and/or gamma-glutamyl transpeptidase (GGT) ?2.5 x ULN during the Screening period (central laboratory results) or a history of these findings when on somatostatin analogue (SSTa) treatment.
    - Has clinically significant pancreatic abnormalities and/or amylase and/or lipase ?1.5 x ULN during the Screening period (central laboratory results).
    - Has any significant renal abnormalities and/or creatinine ?1.5 x ULN during the Screening period (central laboratory results).
    - Has uncontrolled diabetes (glycosylated haemoglobin (HbA1c) ?9%, centrally assessed during the Screening period), or has diabetes treated with insulin for less than 6 months prior to study entry.
    - Has any known uncontrolled cardiovascular disease or had any of the following within 6 months of Screening: ventricular or atrial dysrhythmia ?grade 2, bradycardia ?grade 2, electrocardiogram (ECG) QT interval corrected (QTc) prolonged ?grade 2, myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, hypertension not adequately controlled by current medications.
    - Use of any hormone replacement therapy (HRT) with oestrogens.
    - Has a history of gallstones or any gallstones/sludge observed at Screening gallbladder echography (local assessment).
    - Has abnormal findings during the Screening period, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety.
    - Has been treated with any other investigational medicinal product (IMP) prior to the first study visit without undergoing a washout period of seven times the elimination half life of the investigational compound.
    - Has a known hypersensitivity to any of the test materials or related compounds.
    - Is likely to require treatment during the study with drugs that are not permitted by the study protocol.
    - Has a history of, or known current, problems with alcohol or drug abuse.
    - Has any mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
    No se incluirá en el estudio a los sujetos que:
    - Hayan recibido radioterapia en los 2 años anteriores a la entrada en el estudio.
    - Hayan recibido un tratamiento con un agonista de la dopamina o un agonista del receptor de somatotropina o cirugía hipofisaria en los 3 meses antes de entrar en el estudio.
    - Puedan requerir cirugía hipofisaria o radioterapia durante el estudio.
    - Presenten anomalías hepáticas clínicamente significativas o concentraciones de alanina-aminotransferasa (ALT) o aspartato aminotransferasa (AST) ?3 x LSN o fosfatasa alcalina (FA) ?2,5 x LSN o bilirrubina total ?1,5 x LSN o gamma glutamiltranspeptidasa (GGT) ?2,5 x LSN durante el período de selección (resultados del laboratorio central) o antecedentes de estos resultados durante el tratamiento con un análogo de la somatostatina (SST).
    - Presenten anomalías pancreáticas clínicamente significativas o concentraciones de amilasa o lipasa de ?1,5 x LSN durante el período de selección (resultados del laboratorio central).
    - Presenten alguna anomalía renal significativa o concentraciones de creatinina de ?1,5 x LSN durante el período de selección (resultados del laboratorio central).
    - Sufran diabetes no controlada (hemoglobina glucosilada (HbA1c) ?9%, evaluada en el laboratorio central durante el período de selección), o diabetes tratada con insulina durante menos de 6 meses antes de entrar en el estudio.
    - Sufran alguna enfermedad cardiovascular no controlada o hayan presentado durante los 6 meses anteriores a la selección alguno de los problemas siguientes: arritmia ventricular o auricular ?grado 2, bradicardia ?grado 2, prolongación del intervalo QT corregido (QTc) en el electrocardiograma (ECG) ?grado 2, infarto de miocardio, angina grave o inestable, insuficiencia cardíaca congestiva sintomática, accidente cerebrovascular o accidente isquémico transitorio, embolia pulmonar o hipertensión que no se pueda controlar adecuadamente con los medicamentos actuales.
    - Usen un tratamiento de reposición hormonal (TRH) con estrógenos.
    - Tengan antecedentes de cálculos biliares o se les haya detectado cálculos biliares/ litiasis en la ecografía de la vesícula biliar de la selección (evaluación local).
    - Presenten resultados anómalos durante el período de selección o tengan algún otro problema médico o resultado analítico que, en opinión del investigador, ponga en riesgo su seguridad.
    - Hayan recibido tratamiento con algún otro fármaco en fase de investigación antes de la primera visita del estudio sin que haya transcurrido un período de reposo farmacológico de siete veces la semivida de eliminación del compuesto en fase de investigación.
    - Tengan hipersensibilidad conocida a cualquiera de los materiales de prueba o los compuestos relacionados.
    - Probablemente requieran un tratamiento durante el estudio con fármacos que no están permitidos en el protocolo.
    - Tengan antecedentes o problemas actuales de alcoholismo o drogadicción.
    - Tengan algún problema mental que les vuelva incapaces de comprender la naturaleza, el alcance y las posibles consecuencias del estudio o hayan demostrado una actitud de falta de cooperación.
    E.5 End points
    E.5.1Primary end point(s)
    Safety variables
    - Adverse events
    - Vital signs (supine and standing blood pressure, heart rate, body temperature)
    - Physical examination
    - 12 lead electrocardiogram (ECG), QT interval corrected (QTc) will be calculated using Fridericia methodology
    - Clinical laboratory assessments: haematology, coagulation, clinical biochemistry, urinalysis
    - Glycosylated haemoglobin (HbA1c)
    - Estimated glomerular filtration rate (eGFR) estimated by the Modification of Diet in Renal Disease (MDRD) formula
    - Gallbladder echography
    - Putative antibodies to lanreotide
    - Evaluation of injection site reactions (appearance, local symptoms)

    Pharmacokinetic variables:
    Lanreotide serum concentration

    Lanreotide PK parameters
    -Ctrough
    - maximum serum concentration (Cmax)
    -Tmax
    -area under the serum concentration time curve from time 0 to 85 days (AUC 0-85)
    -area under the concentration time curve extrapolated to infinity (AUC 0-inf)
    -t½
    -mean residence time (MRT)
    -apparent clearance (CL/F)
    -apparent volume of distribution (V/F)

    Excipient serum concentration

    Excipient PK parameters
    -Cmax
    -Tmax
    -area under the serum concentration time curve from time 0 to last quantifiable timepoint (AUCt)
    -AUC 0-inf
    -t½
    -MRT
    -CL/F
    -V/F
    Variables de seguridad:
    Acontecimientos adversos
    - Constantes vitales (presión arterial en decúbito supino y en bipedestación, frecuencia cardíaca y temperatura corporal)
    - Exploración física
    - Intervalo QTc (calculado por el método de Fridericia) con un ECG de 12 derivaciones
    - Evaluaciones analíticas: hematología, coagulación, bioquímica clínica y análisis de orina
    - Hemoglobina glicoxilada (HbA1c)
    - Ratio de filtración glomerular estimado (eGFR) según la fórmula del estudio Modification of Diet in Renal Disease (modificación de la dieta en nefropatía, MDRD)
    - Ecografía de la vesícula biliar
    - Posibles anticuerpos contra la lanreotida
    - Evaluación de las reacciones en la zona de la inyección

    Variables farmacocinéticas:
    - Concentración de lanreotida en suero

    Parámetros farmacocinéticos de lanreotida:
    - Cmín
    - Cmáx
    - Tmáx
    - área bajo la curva de concentración sérica respecto del tiempo entre el momento 0 y los 85 días (AUC0-85)
    - área bajo la curva de concentración-tiempo extrapolada al infinito (AUC 0-inf
    - t½
    - tiempo de permanencia medio (TPM)
    - depuración aparente (CL/F)
    - volumen aparente de distribución (V/F).

    Concentración del excipiente en suero

    Parámetros farmacocinéticos del excipiente:
    - Cmáx
    - Tmáx
    - área bajo la curva de concentración sérica respecto del tiempo desde el momento 0 hasta el último momento cuantificable (AUCt)
    - AUC 0-Inf
    - t½
    - TPM
    - CL/F
    - V/F
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety Variables - Timepoints depend on the type of variable
    Lanreotide serum concentration
    Baseline (predose on Day 1 of lanreotide PRF administration)
    -At 1, 2, 4, 6, 8 and 12 hours postdose on the day of dosing (Day 1)
    -At 24 hours postdose (Day 2)
    -On Days 3 and 5, and at Weeks 2, 3, 5, 9 and 13 after lanreotide PRF administration (the Week 13 sample will be on Day 85 and will correspond to the concentration at the end of the dosing interval (Ctrough))
    -At Weeks 17, 21 and 25 (or EW) during follow up

    Excipient serum concentration
    -Baseline (predose on Day 1 of lanreotide PRF administration)
    -At 1, 2, 4, 6, 8 and 12 hours postdose on the day of dosing (Day 1), at 24 hours postdose (Day 2), and on Days 3 and 5 after lanreotide PRF administration
    Variables de seguridad ? El tiempo depende del tipo de variable.
    Concentración de lanreotida en suero
    Período basal (antes de la administración de la dosis del día 1 de lanreotida de liberación prolongada, LP)
    - Al cabo de 1, 2, 4, 6, 8 y 12 h tras la dosis el día de la administración (día 1)
    - 24 h después de la dosis (día 2).
    - Los días 3 y 5 y las semanas 2, 3, 5, 9 y 13 tras la administración de lanreotida de LP (la muestra de la semana 13 se tomará el día 85 y corresponderá a la concentración al final del intervalo de la dosis (Cmín)).
    - en las semanas 17, 21 y 25 (o en caso de retirada prematura) durante el seguimiento
    Concentración del excipiente en suero
    - Período basal (antes de la administración de la dosis del día 1 de lanreotida de LP).
    - Al cabo (..)
    E.5.2Secondary end point(s)
    Pharmacodynamics variables
    - IGF 1
    - GH cycle (five sampling times with a sample every 30 minutes for 2 hours in the morning)
    - Random GH sample
    - Free triiodothyronine (FT3), free thyroxine (FT4), thyroid stimulating hormone (TSH) and prolactin (PRL)
    Variables farmacodinámicas
    - IGF 1
    - Ciclo de somatotropina (cinco momentos de toma de muestra con una muestra cada 30 minutos durante 2 horas por la mañana)
    - Muestra aleatoria de somatotropina
    - Triyodotironina libre (FT3), tiroxina libre (FT4), hormona estimulante del tiroides (TSH) y prolactina (PRL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    IGF-1: screening, baseline (pre-dose), 6 hrs post-dose on Day 1, Wks 5, 9, 13 and Wks 17, 21 and 25/EW during follow up
    GH cycle: screening, baseline (pre-dose), Wks 5 and 13
    Random GH sample: 6 hrs post dose on Day 1, Wk 9, and Wks 17, 21 and 25/EW during follow up
    FT3/FT4/TSH/PRL: screening, baseline (pre-dose), Wks 2, 5 and 13, and Wk 25/EW during follow up
    IGF-1: en la selección, en el período basal (antes de la dosis del día 1), al cabo de 6 horas tras la dosis el día de la administración (día 1) y en las semanas 5, 9 y 13 y en las semanas 17, 21 y 25 (o en caso de retirada prematura) durante el seguimiento.
    Ciclo de somatotropina: en la selección, en el período basal (antes de la dosis del día 1), en la semana 5 y 13
    Muestra aleatoria de somatotropina6 horas después de la dosis el día de la administración (día 1) y en la semana 9 y en las semanas 17, 21 y 25 (o en caso de retirada prematura) durante el seguimiento.
    FT3/FT4/TSH/PRL: en la selección, en el período basal (antes de la dosis del día 1),en las semanas 2, 5 y 13, y en la semana (o en caso de retirada prematura) durante el seguimiento.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Lithuania
    Netherlands
    Romania
    Russian Federation
    Spain
    United Kingdom
    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 patient, last visit
    Última visita, último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 21
    F.4.2.2In the whole clinical trial 27
    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)
    Treatment after the subject has ended the participation in the trial will be left to the investigator's judgment.
    Una vez finalizada su participación en el ensayo el tratamiento del paciente se dejará a criterio del investigador
    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 Decision2016-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-28
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