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    Summary
    EudraCT Number:2020-006118-19
    Sponsor's Protocol Code Number:2020-012-00EU1
    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:2021-07-27
    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 number2020-006118-19
    A.3Full title of the trial
    An Open-Label Phase 2 Study of Surufatinib in Patients with Neuroendocrine Tumours in Europe
    Estudio abierto en fase II de surufatinib en pacientes con tumores neuroendocrinos en Europa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-Label Phase 2 Study of Surufatinib in Patients with Neuroendocrine Tumours in Europe
    Estudio abierto en fase II de surufatinib en pacientes con tumores neuroendocrinos en Europa
    A.4.1Sponsor's protocol code number2020-012-00EU1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04579679
    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 SponsorHutchison MediPharma Limited
    B.1.3.4CountryUnited States
    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 supportHutchison MediPharma Limited
    B.4.2CountryChina
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHutchison MediPharma Limited
    B.5.2Functional name of contact pointNick Lawn
    B.5.3 Address:
    B.5.3.1Street Address25A Vreeland Road, Suite 304, Florham Park
    B.5.3.2Town/ cityNJ
    B.5.3.3Post code07932
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1973826 2891
    B.5.6E-maileunet@hmplglobal.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 nameSurufatinib
    D.3.2Product code HMPL-012
    D.3.4Pharmaceutical form Capsule, hard
    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 INNSURUFATINIB
    D.3.9.1CAS number 1308672-74-3
    D.3.9.2Current sponsor codeHMPL-012
    D.3.9.3Other descriptive nameSurufatinib
    D.3.9.4EV Substance CodeSUB194701
    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
    Neuroendocrine Tumours
    Tumores Neuroendocrinos
    E.1.1.1Medical condition in easily understood language
    Neuroendocrine Tumours
    Tumores Neuroendocrinos
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052399
    E.1.2Term Neuroendocrine tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the anti-tumour activity of surufatinib in patients with low- to intermediate-grade (Grade 1 or Grade 2), well differentiated NET
    Evaluar la actividad antitumoral de surufatinib en pacientes con TNE bien diferenciados o de grado bajo a intermedio (grado 1 o grado 2).
    E.2.2Secondary objectives of the trial
    - To characterise the PK of surufatinib in patients with NET
    - To evaluate the effect of surufatinib on cardiac repolarisation, as detected by changes in ECG QTc, and the potential relationship with surufatinib plasma concentrations
    - To further characterise the antitumour activity of surufatinib in patients with NET
    - Cohort D only: To evaluate the effects of repeat dosing of surufatinib on the single-dose PK of CYP3A4, P-gp, and BCRP) substrates in patients with NET
    - To evaluate the safety and tolerability of surufatinib in patients with NET
    - Caracterizar la farmacocinética (FC) de surufatinib en pacientes con TNE.
    - Evaluar el efecto de surufatinib en la repolarización cardíaca, detectado por los cambios en los intervalos QT corregidos del electrocardiograma (ECG), y la posible relación con las concentraciones plasmáticas de surufatinib.
    - Caracterizar mejor la actividad antitumoral de surufatinib en pacientes con TNE.
    - (Cohorte D solamente): Evaluar los efectos de la administración repetida de dosis de surufatinib en la FC de dosis única de sustratos del citocromo P450 [CYP]3A4, la glucoproteína P [gp-P] y la proteína de resistencia al cáncer de mama [BCRP] en pacientes con TNE.
    - Evaluar la seguridad y tolerabilidad de surufatinib en pacientes con TNE.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Cohort D (Drug-Drug Interaction [DDI] Sub-Study): The primary objective of this cohort is to investigate the potential DDI between surufatinib and a drug cocktail containing selective probes of CYP3A4 (midazolam), P-gp (fexofenadine), and BCRP (rosuvastatin) substrates.
    Cohorte D (subestudio de interacción farmacológica [IF]): el objetivo principal de esta cohorte es investigar la potencial IF entre surufatinib y un cóctel farmacológico con sustratos seleccionados de CYP3A4 (midazolam), P-gp (fexofenadina) y BCRP (rosuvastatina).
    E.3Principal inclusion criteria
    1. Has histologically or cytologically documented, locally advanced, or metastatic NET and has progressed on at least 1 prior line of therapy, but no more than 3 therapies:
    a. Cohort A: NET of lung origin
    b. Cohort B: NET of small bowel origin
    c. Cohort C: NET of non-small bowel, non-pancreas, and non-lung origin
    d. Cohort D (DDI substudy): NET of any origin
    2. Has radiologic evidence of progressive tumour within 12 months of study enrolment
    3. Is willing and able to provide informed consent
    4. Is ≥18 years of age
    5. Has measurable lesions according to RECIST Version 1.1
    6. Has absolute neutrophil count of ≥ 1.5×109/L, platelet count of ≥ 100×109/L, and haemoglobin ≥ 9 g/dL
    7. Has serum total bilirubin <1.5 times the upper limit of normal (ULN)
    8. Has proteinuria <2+ by urinalysis, or 24-hour urine collection ≤1 g of protein, or urine protein: urine-creatinine ratio ≤1.9
    9. Has alanine aminotransferase (ALT), AST, or alkaline phosphatase levels ≤ 2.5 times the ULN
    a. Patients with known liver metastases may have ALT, AST, and ALP ≤3× the ULN
    10. Has serum creatinine <1.5 times ULN or creatinine clearance ≥ 60 mL/min
    11. International normalised ratio (INR) >1.5 or activated partial thromboplastin time (aPTT) >1.5×ULN
    12. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    13. Female patients of childbearing potential and male patients with partners of childbearing potential agree to use a highly effective form(s) of contraception that results in a low failure rate (<1% per year) when used consistently and correctly, starting during the screening period, continuing throughout the entire study period, and for 90 days after taking the last dose of study drug. Such methods include oral hormonal contraception (combined oestrogen/progestogen or progestogen only) or highly effective non-oral hormonal contraception (e.g., Depo-Provera and Implanon) associated with inhibition of ovulation together with a barrier method (e.g., diaphragm, always containing a spermicide), intrauterine device, intrauterine hormone-releasing system, bilateral tubal ligation, vasectomized partner, or sexual abstinence in line with the preferred and usual lifestyle of the subject. Oral and non-oral hormonal contraception should always be combined with an additional contraceptive method (i.e., barrier method) because of a potential interaction with the study drug. The same criteria are applicable to male patients involved in this clinical study if they have a partner of childbirth potential, and male patients must always use a condom.
    1. Tener TNE localmente avanzado o metastásico documentado histológica o citológicamente y que haya progresado con al menos 1 línea previa de tratamiento, pero no más de 3 tratamientos:
    a. Cohorte A: TNE de origen pulmonar
    b. Cohorte B: TNE de origen en el intestino delgado
    c. Cohorte C: TNE que no tenga su origen en el intestino delgado, el páncreas y el pulmón
    d. Cohorte D (subestudio de IF): TNE de cualquier origen
    2. Presentar indicios radiológicos de tumor progresivo en los 12 meses previos a la inscripción en el estudio.
    3. Estar dispuesto y ser capaz de proporcionar el consentimiento informado.
    4. Tener ≥18 años de edad.
    5. Tener lesiones medibles según los criterios RECIST versión 1.1 (Apéndice 2 [Sección 15])
    6. Tener un recuento absoluto de neutrófilos ≥1,5 × 109/l, recuento de plaquetas ≥100×109/l y hemoglobina ≥9 g/dl.
    7. Bilirrubina total sérica <1,5 × límite superior de la normalidad (LSN).
    8. Proteinuria <2+ mediante análisis de orina, o recogida de orina de 24 horas ≤1 g de proteínas o cociente de proteínas en orina:creatinina en orina ≤1,9.
    9. Niveles de alanina aminotransferasa (ALT), AST o fosfatasa alcalina ≤2,5 veces el LSN.
    a. Los pacientes con metástasis hepáticas conocidas pueden tener ALT, AST y ALP ≤3× LSN.
    10. Creatinina sérica <1,5 veces el LSN o aclaramiento de creatinina ≥60 ml/min calculado mediante la fórmula de Cockcroft-Gault.
    11. Índice internacional normalizado (INR) >1,5 o tiempo de tromboplastina parcial activada (TTPa) >1,5 × LSN (en el caso de los pacientes tratados con warfarina o productos similares a la cumadina, consulte la Sección 7.3.3).
    12. Estado funcional de 0 a 1 conforme a la escala del Grupo Oncológico Cooperativo del Este (ECOG) (Apéndice 1 [Sección 15]).
    13. Las mujeres en edad fértil y los hombres con parejas en edad fértil aceptan utilizar una o varias formas altamente eficaces de anticoncepción, que se traduce en una baja tasa de fracaso (<1 % por año) cuando se utiliza de manera constante y correcta, comenzando durante la fase de selección, continuando a lo largo de todo el periodo del estudio, y durante 90 días después de tomar la última dosis del fármaco del estudio. Entre estos métodos se incluyen la anticoncepción hormonal oral (estrógeno/progestágeno combinado o solo progestágeno) o la anticoncepción hormonal no oral altamente eficaz (p. ej., Depo-Provera e Implanon) asociada a la inhibición de la ovulación junto con un método de barrera (por ejemplo, el diafragma, que siempre contiene un espermicida), el dispositivo intrauterino, el sistema intrauterino liberador de hormonas, la ligadura de trompas bilateral, la vasectomía de la pareja o la abstinencia sexual en línea con el estilo de vida preferido y habitual del sujeto. La anticoncepción hormonal oral y no oral siempre debe combinarse con un método anticonceptivo adicional (es decir, un método de barrera) debido a una posible interacción con el fármaco del estudio. Los mismos criterios son aplicables a los pacientes varones que participan en este ensayo clínico si tienen una pareja en edad fértil, y estos deben utilizar siempre un preservativo.
    E.4Principal exclusion criteria
    1. Has an AE due to previous anti-tumour therapy that has not recovered to ≤CTCAE Grade 1, except alopecia and peripheral neurotoxicity with ≤CTCAE Grade 2 caused by platinum chemotherapy
    2. Major surgery within previous 4 weeks or radiation therapy within 2 weeks prior to the start of treatment. Prior palliative radiotherapy for metastatic lesions is permitted if there is at least one measurable lesion that has not been irradiated.
    3. Prior VEGF/VEGFR-targeted therapy
    4. Has uncontrollable hypertension, defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, despite antihypertensive medication
    5. PT/INR >1.5 or activated partial thromboplastin time (aPTT)>1.5×ULN. For patients on Coumadin or coumadin-like products, please
    refer to Section 7.3.3)
    6. Has gastrointestinal disease or condition within 6 months prior to first dose that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumour with active bleeding, or other gastrointestinal conditions that could, in the investigators judgment, result in bleeding or perforation
    7. Has a history or presence of a serious haemorrhage (>30 mL within 3 months) or haemoptysis (>5 mL blood within 4 weeks) within 6 months of first dose of study drug
    8. Has clinically significant cardiovascular disease, including, but not limited to, acute myocardial infarction within 6 months prior to enrolment, severe/unstable angina pectoris or coronary artery bypass
    grafting, congestive heart failure ≥2 according to the New York Heart Association classification, ventricular arrhythmia that needs drug treatment, and left ventricular ejection fraction (LVEF) <50%
    9. Has a mean corrected QT interval by Fridericia (QTcF) ≥480 ms
    10. Has brain metastases and/or spinal cord compression untreated with surgery and/or radiotherapy, and without clinical imaging evidence of stable disease (SD) for 14 days or longer; patients requiring steroids within 4 weeks prior to start of study treatment will be excluded
    11. Has a high risk of bleeding at screening due to tumour invasion into major vessels, such as pulmonary artery, the superior vena cava, or the inferior vena cava, as determined by investigators
    12. Has arterial thrombosis or deep venous thrombosis within 6 months prior to first dosing, or thromboembolic events (including stroke and/or transient ischaemic attack) within 6 months prior to first dose of study drug
    13. Use of strong inducers or inhibitors of CYP3A4 within 2 weeks before the first dose of surufatinib
    14. For Cohort D, use of medications that are known substrates, inhibitors, or inducers of CYP3A or substrates of P-gp or BCRP within 3 weeks before the first dose of the drug cocktail
    15. Prior history of other cancer except those treated with curative intent for in situ nonmelanoma skin cancer, breast, or cervical cancer, or those treated with curative intent and no evidence of disease in the last 5 years prior to enrolment in the study
    16. Has a clinically meaningful ongoing infection (eg, requiring intravenous treatment with anti-infective therapy)
    a. See Appendix 8 for procedures specific to subjects with suspected or confirmed coronavirus disease 2019 (COVID-19)
    17. Has clinical symptoms consistent with pancreatitis
    18. Has a history of allergies to any ingredient of surufatinib or its capsule shell, including tartrazine (E 102)
    1. Presenta un AA debido a un tratamiento antitumoral previo que no se ha recuperado hasta grado ≤1 según los CTCAE, excepto alopecia y neurotoxicidad periférica de grado ≤2 según los CTCAE causada por quimioterapia con platino.
    2. Cirugía mayor en las 4 semanas anteriores o radioterapia en las 2 semanas previas al inicio del tratamiento. Se permite la radioterapia paliativa previa para lesiones metastásicas si hay al menos una lesión medible que no haya sido irradiada.
    3. Tratamiento previo dirigido a VEGF/VEGFR
    4. Tener hipertensión incontrolable, definida como tensión arterial sistólica ≥140 mmHg y/o presión arterial diastólica ≥90 mmHg, a pesar de la medicación antihipertensiva.
    5. TP/RIN>1.5 o tiempo de tromboplastina parcial activada (TTPa) >1.5×ULN. Para pacientes con Coumadin or derivados de coumadin, por favor refiérase a la Sección 7.3.3)
    6. Tener enfermedad o afección gastrointestinal en los 6 meses anteriores a la primera dosis que los investigadores sospechen que puede afectar a la absorción del fármaco, incluidas, entre otras, úlceras gástricas y duodenales activas, colitis ulcerosa y otra enfermedad digestiva, tumor gastrointestinal con hemorragia activa u otras afecciones gastrointestinales que podrían, a juicio del investigador, provocar hemorragia o perforación.
    7. Antecedentes o presencia de una hemorragia grave (>30 ml en los 3 meses previos) o hemoptisis (>5 ml de sangre en las 4 semanas previas) en los 6 meses anteriores a la primera dosis del fármaco del estudio.
    8. Enfermedad cardiovascular de importancia clínica, incluyendo, entre otras, infarto agudo de miocardio en los 6 meses anteriores a la inscripción, angina de pecho grave o inestable o injerto de derivación aortocoronaria, insuficiencia cardíaca congestiva ≥2 según la clasificación de la Asociación Cardiaca de Nueva York (New York Heart Association), arritmia ventricular que requiera tratamiento farmacológico y fracción de eyección del ventrículo izquierdo (FEVI) <50 %.
    9. Tener un intervalo QT corregido medio por Fridericia (QTCf) ≥480 ms.
    10. Metástasis cerebrales y/o compresión de la médula espinal no tratadas con cirugía y/o radioterapia, y sin indicios de enfermedad estable (EE) en los estudios de imagen clínicos durante 14 días o más; se excluyen los pacientes que requieran corticoesteroide en las 4 semanas previas al inicio del tratamiento del estudio.
    11. Presentar un alto riesgo de hemorragia en el momento de la selección debido a la invasión tumoral en los vasos principales, como la arteria pulmonar, la vena cava superior o la vena cava inferior, según lo determinado por los investigadores.
    12. Trombosis arterial o trombosis venosa profunda en los 6 meses anteriores a la primera dosis, o acontecimientos tromboembólicos (incluidos accidente cerebrovascular y/o accidente isquémico transitorio) en los 6 meses anteriores a la primera dosis del fármaco del estudio.
    13. Uso de inductores o inhibidores potentes de CYP3A4 en las 2 semanas anteriores a la primera dosis de surufatinib (véase el Apéndice 3 [Sección 15] para conocer ejemplos).
    14. Para la cohorte D, uso de medicamentos que son sustratos, inhibidores o inductores conocidos del CYP3A o sustratos de la gp-P o BCRP en las 3 semanas anteriores a la primera dosis del cóctel de fármacos (véase el Apéndice 3 [Sección 15] para conocer ejemplos).
    15. Antecedentes de otro cáncer excepto aquellos tratados con intención curativa para cáncer cutáneo no melanómico in situ, de mama o de cuello uterino, o aquellos tratados con intención curativa y sin evidencia de enfermedad en los últimos 5 años antes de la inscripción en el estudio.
    16. Una infección en curso clínicamente significativa (p. ej., que requiera tratamiento intravenoso con tratamiento antiinfeccioso).
    a. Véase el Apéndice 8 para conocer los procedimientos específicos de sujetos con sospecha o confirmación de enfermedad por coronavirus 2019 (COVID-19).
    17. Síntomas clínicos compatibles con pancreatitis.
    18. Antecedentes de alergias a cualquier componente de surufatinib o la cubierta de la cápsula, incluida la tartrazina (E 102).
    E.5 End points
    E.5.1Primary end point(s)
    Disease Control Rate (DCR)
    Tasa de Control de la Enfermedad (TCE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 meses
    E.5.2Secondary end point(s)
    - Observed plasma concentrations, estimated population PK, and exposure parameters of surufatinib
    - QTc and plasma concentrations of surufatinib at specified time points
    - Additional efficacy endpoints
    • Objective Response Rate (ORR)
    • Time to Response (TTR)
    • Duration of Response (DoR)
    • Progressive-Free Survival (PFS)
    - Cohort D only: Exposure parameters of CYP3A4, P-gp, and BCRP substrates
    - Safety assessments include:
    • Frequency and severity of AEs
    • Physical examination findings
    • Vital signs
    • Laboratory tests
    • ECG
    • Echocardiograms/MUGA
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK Plasma Sampling: Day (-1 & -2) & at specific timepoints as per Schedule of Events (SOE)
    ECG for QTc Evaluation: At pre & post-dose on Cycle 1 Day 1 and Cycle 1 Day 15 (+1 week) at specific time points given in SOE
    ORR: Time to attain best overall response or CR or PR per RECIST Version 1.1
    TTR: Time between the start date of study drug until first documented response (CR or PR) according to RECIST Version 1.1
    DoR: Timepoint at which the objective response reaches CR or PR, whichever comes first, until the occurrence of PD or death
    PFS: Time from the start of study drug to date of objective disease progression as defined by RECIST Version 1.1 or death, whichever comes first.
    Echocardiogram/MUGA: At screening, Every 12 weeks (±7 days) after the first dose
    AEs, SAEs: Screening, EOT
    Día de muestra FC de plasma (-1 & -2) y en momentos específicos según el calendario de acontecimientos (CdA).
    ECG para Evaluación QTc: antes y después de la dosis en Ciclo 1 Día 1 y Ciclo 1 Día 15 (+1 semana) en momentos específicos dados por el CdA.
    TRO: tiempo para alcanzar la mejor respuesta general o RC o RP según RECIST Versión 1.1
    TDR: tiempo entre la fecha de inicio del fármaco de estudio hasta la primera respuesta documentada (RC o RP) de acuerdo a RECIST Versión 1.1
    DDLR: momento en el el objetivo de respuesta alcanza una RC o RP, la primera que ocurra, hasta que ocurra EP o muerte.
    SLP: tiempo desde el inicio del fármaco del estudio a la fecha de la progresión objetiva de la enfermedad definida por RECIST Version 1.1 o muerte, lo que ocurra antes.
    Ecocardiograma/MUGA [...]
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Tolerability, Drug-drug interaction (DDI)
    Tolerabilidad, Interacción Farmácologica (IF)
    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) 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    France
    Germany
    Italy
    Norway
    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
    LVLS
    UVUP
    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 months6
    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 months6
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 76
    F.4.2.2In the whole clinical trial 76
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusOngoing
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