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    EudraCT Number:2019-003106-28
    Sponsor's Protocol Code Number:73841937NSC2001
    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:2019-11-06
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-003106-28
    A.3Full title of the trial
    A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
    Estudio fase I/II, abierto, multicéntrico para evaluar la seguridad, tolerabilidad, farmacocinética y actividad antitumoral de YH25448 en pacientes con cáncer de pulmón no microcítico avanzado con mutación EGFR positiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Tumor Activity of YH25448 in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
    Un estudio para evaluar la seguridad, tolerabilidad, farmacocinética y actividad antitumoral de YH25448 en pacientes con mutación positiva de EGFR con cáncer de pulmón no microcitico avanzado
    A.4.1Sponsor's protocol code number73841937NSC2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03046992
    A.5.4Other Identifiers
    Name:YH25448-201Number:Yuhan Corporation
    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 SponsorJanssen Research & Development, LLC
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.4Telephone number0034672603668
    B.5.5Fax number0034917228628
    B.Sponsor: 2
    B.1.1Name of SponsorYuhan Corporation
    B.1.3.4CountryKorea, Republic of
    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 supportYuhan Corporation
    B.4.2CountryKorea, Republic of
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A.
    B.5.2Functional name of contact pointGlobal Clinical
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.4Telephone number0034672603668
    B.5.5Fax number0034917228628
    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 namelazertinib
    D.3.2Product code YH25448A/JNJ-73841937-ABV
    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 INNLazertinib
    D.3.9.1CAS number 2247995-37-3
    D.3.9.2Current sponsor codeYH25448A/JNJ-73841937-ABV
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
    Cáncer de pulmón no microcitico avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer called "Non-Small Cell Lung Cancer"
    Un tipo específico de cáncer llamado "cáncer de pulmón no microcitico"
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Part D of the trial is to evaluate the safety, tolerability and pharmacokinetic (PK) of YH25448 when given orally to patients with EGFRm+ locally advanced or metastatic NSCLC.
    El objetivo principal de la parte D del estudio es evaluar la seguridad, tolerabilidad y farmacocinética (FC) de YH25448 cuando se administra por vía oral a pacientes con CPNM localmente avanzado o metastásico y mutación del EGFR (EGFRm) positiva.
    E.2.2Secondary objectives of the trial
    The secondary objectives of Part D of the trial are:
    1. To characterize the PK profiles of potential YH25448 metabolites in plasma, including M7, following a single oral dose and at steady state.
    2. To obtain additional assessments of the anti-tumor activity of YH25448 by evaluation of overall response rate (ORR), duration of response (DoR), disease control rate (DCR), tumor shrinkage and progression free survival (PFS) using RECIST 1.1 as assessed by investigator review of radiological information and overall survival (OS).
    Los objetivos secundarios de la parte D del estudio son:
    1. Caracterizar los perfiles FC de los metabolitos potenciales de YH25448, incluido M7, después de la administración de una dosis oral única y en estado estacionario.
    2. Obtener evaluaciones adicionales de la actividad antitumoral de YH25448 mediante la evaluación de la TRO (tasa de respuesta objetiva), la DdR (duración de la respuesta), la TCE (tasa de control de la, reducción tumoral), la reducción del tumor y la SSP (supervivencia sin progresión) mediante los criterios RECIST 1.1 evaluados por una revisión central independiente de la información radiológica y SG (supervivencia global).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, patients must fulfill all of the following criteria.
    1. Signed Written Informed Consent
    ● Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses. For inclusion in optional genetic and/or biomarker research, patients must provide informed consent for the research.
    2. Age and Sex
    ● At least 20 years of age and older or adult men and women for each country.
    ● Females should agree to use adequate contraceptive measure, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of following criteria at screening:
    - Post-menopausal defined as aged more than 50 years and ameorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.
    - Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
    - Women under 50 years old would be considered postmenopausal if they have been ameorrhoeic for at least 12 months following cessation of exogenous hormonal treatment, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in postmenopausal range for the institution.
    ● Male patients who have not undergone a vasectomy must agree to use barrier contraception i.e. condoms, and refrain from donating sperm until 3 months after last drug is taken.
    ● During the study, and for 3 months after receiving the last dose of study drug, female patients must agree not to donate eggs (ova, oocytes) and male patients must agree not to donate sperm for the purposes of assisted reproduction.
    3. Target disease
    ● In Part D: Patients outside Korea with histologically or cytologically (ie, using pleural effusion, ascites) confirmed NSCLC with previously diagnosed EGFRm+, and who have had progressive disease on prior EGFR-TKI therapy.
    ● Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 3 months.
    ● Patients who have at least one measurable extracranial lesion, not previously irradiated and not chosen for biopsy during the study screening period or one measurable lesion that has passed 14 days or more after biopsy, that can be accurately measured at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), are suitable for accurate repeated measurement.
    Para ser incluidos en el estudio, los pacientes deben cumplir todos siguientes criterios:
    1. Haber firmado el Consentimiento Informado
    •La obtención del Consentimiento Informado fechado y firmado es necesario antes de que se lleve a cabo cualquier procedimiento específico del estudio, obtención de muestras o de análisis. Para la inclusión opcional en investigación genética y/o biomarcadores los pacientes deben dar su consentimiento a dicha investigación.
    2. Edad y Sexo
    •Tener 20 años o más y ser un hombre o mujer considerado adulto para el país.
    •Las mujeres deben aceptar usar medidas anticonceptivas adecuadas, no deben estar amamantando y deben tener una prueba de embarazo negativa antes del inicio de la dosis si la mujer puede concebir o dar evidencia de la imposibilidad de concebir cumpliendo uno de los siguientes criterios en el proceso de selección:
    -Posmenopausia definida como tener más de 50 años con amenorrea durante al menos 12 meses después del cese de todos los tratamientos hormonales exógenos.
    -Documentación de esterilización quirúrgica irreversible por histerectomía bilateral o salpingectomía bilateral pero no ligadura de trompas.
    -Las mujeres con menos de 50 se considerarán posmenopáusicas si han estado con amenorrea durante al menos 12 meses después de la interrupción del tratamiento hormonal exógeno, y tienen niveles en el rango posmenopáusico de hormona foliculoestimulante (FSH) y hormona luteinizante (LH) para la institución.
    •Los pacientes varones que no se hayan sometido a una vasectomía deben aceptar el uso de
    anticonceptivos de barrera, es decir, condones, y abstenerse de donar esperma hasta 3 meses después de tomar el último medicamento.
    •Durante el estudio, y durante los 3 meses siguientes a tomar la última dosis del medicamento en investigación, los pacientes que sean mujeres deben aceptar no donar óvulos (óvulos, ovocitos) y los pacientes que sean hombres deben aceptar no donar esperma con fines de reproducción asistida.
    3. Enfermedad objetivo:
    •En la parte D: Pacientes fuera de Corea con CPNM confirmado histológica o citológicamente (es decir, mediante derrame pleural, ascitis) con EGFRm positiva diagnosticada previamente, y con enfermedad progresiva previamente tratada con un TKI del EGFR.
    •Pacientes con estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 a 1 sin deterioro durante las dos semanas anteriores y una esperanza de vida mínima de 3 meses.
    •Pacientes con al menos una lesión extracraneal medible, no irradiada previamente y no elegida para biopsia durante el período de selección del estudio, o una lesión medible en la que hayan pasado 14 días o más después de la biopsia, que pueda medirse en momento basal con precisión con > =10 mm en diámetro mayor (excepto los ganglios linfáticos que deben tener eje corto >=15 mm) en un TAC (tomografía axial computarizada) o RM (resonancia magnética), son adecuados para mediciones repetidas precisas.
    E.4Principal exclusion criteria
    Patients must not enter the study if any of the following exclusion criteria are fulfilled.
    1. Intervention with any the following:
    ● An unapproved investigational product from another clinical study within 30 days of the first dose of study treatment
    ● Treatment with an EGFR TKIs within 8 days or approximately 5x half-life, whichever is the longer, of the first dose of study treatment or other investigational products within approved indication of marketed product
    ● Any cytotoxic chemotherapy or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen within 14 days of the first dose of study treatment
    ● Major surgery (excluding for vascular access) within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study
    ● Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment with the exception of patients receiving radiation to more than 30% of the bone marrow marrow which must be completed within 4 weeks of the first dose of study treatment
    ● Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of YH25448) medications or herbal supplements known to be inhibitors or inducers of CYP3A4
    ● Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting 1st study treatment with the exception of alopecia
    2. Medical History and Concurrent Disease
    ● Symtomatic spinal cord compression (if steroid treatment is not required within at least 2 weeks prior to the start of the study treatment then the patient may be enrolled)
    ● Brain metastases with symptomatic and/or requiring emergency treatment
    ● Intracranial hemorrhage with symptomatic and/or requiring treatment
    ● CNS complications that require urgent neurosurgical intervention
    ● Leptomeningeal metastasis prior to study treatment
    ● Past medical history of interstitial lung disease (ILD), drug-induced IDL, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
    ● Carcinoma besides NSCLC requiring treatment or any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in trial or which would jeopardise compliance with the protocol. Screening for chronic condition is not required
    ● Any cardiovascular disease as followed,
    a) History of symptomatic CHF or serious cardiac arrhythmia requiring treatment
    b) History of myocardial infarction or unstable angina within 6 months of the first dose of study treatment
    c) LVEF <50%
    ● Active hepatitis with HbsAg+ or anti-HCV Ab+, confirmed positive HIV test results
    ● Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of study medication
    ● History of hypersensitivity to active or inactive excipients of YH25448 or drugs with a similar chemical structure or class to YH25448
    ● Clinically significant chronic infection or significant medical or psychiatric illness
    ● Judgment by investigators that the patient should not participate in the study if the patient is unlikely to comply with study procedure, restrictions and requirements
    ● In addition, the following are considered criterion for exclusion from the exploratory genetic research: Previous allergenic bone marrow transplant, Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
    3. Cardiac and Clinical Laboratory Criteria
    ● Any of following cardiac criteria:
    a) Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 electrocardiograms (ECGs), using the screening ECG machine derived QTc value
    b) Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG eg, complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250msec
    c) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or administration of concomitant medication known to prolong the QT interval
    ● Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values;
    a) Absolute neutrophil count (ANC) < 1.5 x 10^9/L
    b) Platelet count < 100 x 10^9/L
    c) Hemoglobin <90 g/L
    d) Alanine aminotransferase (ALT) >2.5 times the upper limit of normal (UNL) if no demonstrable liver metastases or 5 times ULN in presence of liver metastases
    Pacientes que tengan cualquier criterios de exclusión no deben entrar en el estudio
    1. Intervención con cualquiera de los siguientes
    •Producto en investigación no aprobado de otro estudio clínico dentro de los 30 días de la primera dosis de tto del estudio
    •Tto con un EGFR TKI en los 8 días o aprox 5 veces la vida media, lo que dure más, de la primera dosis del ttto del estudio u otros productos en investigación dentro de las indicaciones aprobadas del producto comercializado
    •Cualquier quimioterapia citotóxica u otros medicamentos contra el cáncer para el tto de CPNM avanzado de un régimen de tto previo dentro de los 14 días de la primera dosis de tto del estudio
    •Cirugía mayor (excl acceso vascular) en las 4 semanas previas a la primera dosis del tto del estudio o una necesidad anticipada durante el estudio
    •Radioterapia con un amplio campo de radiación en las 4 semanas o radioterapia con un campo limitado de radiación para paliación dentro de la primera semana de la primera dosis del tto del estudio, con la excepc. de pacientes que reciben radiación en más del 30% de la médula ósea que debe completarse en las 4 semanas de la primera dosis del tto del estudio
    •Pacientes que actualmente reciben (o no pueden dejar de usar al menos 1 semana antes de recibir la primera dosis de YH25448) medicamentos o suplementos herbales inhibidores o inductores de CYP3A4
    •Cualquier toxicidad no resuelta de la terapia previa, > Grado 1 según CTCAE al momento de comenzar el primer tto del estudio, excepto con alopecia
    2. Historial médico y enfermedad concurrente
    •Compresión sintomática de la médula espinal (si no se requiere tto con corticoides al menos 2 semanas antes del inicio del tto del estudio, el paciente puede ser incluido)
    •Metástasis cerebrales en tto sintomático o que requieran tto de urgencia
    •Hemorragia intracraneal en tto sintomático o que requiera tto.
    •Complicaciones del SNC que requieran una intervención neuroquirúrgica urgente
    •Metástasis leptomeníngeas
    •Antecedentes médicos de enfermedad pulmonar intersticial, EPI inducida por fármacos, neumonitis por radiación que haya requerido tto con corticoides o cualquier evidencia de EPI clínicamente activa.
    •Carcinoma además del NSCLC que requiera tto o cualquier evidencia de enfermedades sistémicas graves o no controladas, incluida hipertensión no controlada y diátesis hemorrágicas activas, que en opinión del investigador, sea deseable que el paciente participe o que ponga en peligro el cumplimiento del protocolo. No se requiere la detección de enfermedades crónicas
    •Cualquiera de las siguientes enfermedades cardiovasculares
    a) Antecedentes de ICC sintomática o arritmia cardíaca grave que requiera tto
    b) Antecedentes de infarto de miocardio o angina inestable en los 6 meses previos a la primera dosis del tto del estudio
    c) FEVI <50 %
    •Hepatitis activa con HbsAg + o anti-VHC Ab +, resultados positivos confirmados de VIH
    •Náuseas y vómitos refractarios, enfermedades gastrointestinales crónicas, incapacidad para tragar el fármaco o resección intestinal previa significativa que impediría la absorción adecuada del mismo
    •Historial de hipersensibilidad a excipientes activos o inactivos de YH25448 o medicamentos con una estructura química o clase similar a YH25448
    •Infección crónica clínicamente significativa o enfermedad médica o psiquiátrica significativa
    •Criterio medico de que el paciente no debe participar si es improbable que el paciente cumpla con los procedimientos, las restricciones y los requisitos del estudio
    •Además, se consideran los siguientes criterios para la exclusión de la investigación genética exploratoria: trasplante de médula ósea alergénica previa, transfusión de sangre completa sin leucocitos en los 120 días previos a la fecha de recolección de la muestra genética
    3. Criterios de laboratorio clínico y cardíaco
    •Cualquiera de los siguientes criterios cardíacos
    a) Intervalo QT corregido en reposo > 470 mseg obtenido de 3 ECG, utilizando el valor QTc derivado de la máquina de ECG de cribado
    b) Cualquier anormalidad clínicamente importante en el ritmo, conducción o morfología del ECG en reposo, p.e. bloqueo completo de rama izquierda, bloqueo cardíaco de tercer grado, bloqueo cardíaco de segundo grado, intervalo PR> 250 mseg
    c) Cualquier factor que aumente el riesgo de prolongación de QTc o riesgo de eventos arrítmicos como insuficiencia cardíaca, hipocalemia, síndrome de QT largo congénito, antecedentes familiares de síndrome de QT largo o muerte súbita inexplicada < 40 años en familiares de primer grado o administración de medicación concomitante que prolongue el intervalo QT
    •Inadecuada reserva de médula ósea u función del órgano según los siguientes valores
    a) Recuento absoluto neutrófilos <1.5 x 10 ^ 9 / L
    b) Recuento plaquetas <100 x 10 ^ 9 / L
    c) Hemoglobina <90 g / L
    d) Alanina aminotransferasa (ALT)> 2.5 UNL si no hay metástasis hepáticas demostrables o >5 ULN si hay metástasis hepáticas
    E.5 End points
    E.5.1Primary end point(s)
    Safety, tolerability, and PK of YH25448
    Seguridad, Tolerabilidad y farmacocinética de YH25448
    E.5.1.1Timepoint(s) of evaluation of this end point
    At each dose level(s) of dose escalation phase in NSCLC patients who progressed following prior EGFR TKIs treatment and harbouring confirmed T790M mutation
    En cada nivel de dosis de la fase de escalado de dosis en pacientes con CPNM que progresaron después del tratamiento previo con EGKT TKI y que albergan la mutación T790M confirmada
    E.5.2Secondary end point(s)
    1. Pharmacokinetic (PK) profiles of potential YH25448 metabolites in plasma, including M7, following a single oral dose and at steady state
    2. Overall response rate (ORR)
    3. Duration of response (DoR)
    4. Disease control rate (DCR)
    5. Tumor shrinkage
    6. Progression free survival (PFS)
    7. Overall survival (OS)
    1.Perfiles de farmacocinética(FC) de metabolitos potenciales de YH25448 en plasma, incluyendo M7, después de la administración de una dosis oral única y en estado de equilibrio.
    2.Tasa de respuesta global (TRG)
    3.Duración de la respuesta (DdR)
    4.Tasa de control de la enfermedad (TCE)
    5.Reducción tumoral
    6.Supervivencia libre de progresión (SLP)
    7.Supervivencia Global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Cycle 0 (Day 1[D1], D2, D3), Cycle 1 (D1, D8, D15), Cycle 2
    2 to 7. Screening, Cycle 1 (D1, D8, D15), Cycle 2 (D1) until follow up visit
    1. Ciclo 0 (Dia 1[D1], D2, D3), Ciclo 1 (D1, D8, D15), Ciclo 2
    2 al 7. Selección, Ciclo 1 (D1, D8, D15), Ciclo 2 (D1) hasta la visita de 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    Safety, tolerability, efficacy and pharmacokinetic (PK) in patients outside of Korea
    Seguridad, tolerabilidad, eficacia y farmacocinética (FC) en pacientes fuera de Korea
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United Kingdom
    United States
    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
    UVUP (Ultima Visita Ultimo Paciente)
    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 months8
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 30
    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)
    Standard of care
    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 Decision2019-11-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-25
    P. End of Trial
    P.End of Trial StatusCompleted
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