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    Summary
    EudraCT Number:2014-002389-62
    Sponsor's Protocol Code Number:8-55-52030-309
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-03-10
    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 ConcernedItaly - Italian Medicines Agency
    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 parmacodynamics of a single dose of lanreotide PRF in subjects with acromegaly previously treated and controlled with ocreotide LAR
    Studio in aperto di fase IIa, a dose crescente, per determinare la dose massima tollerata, la sicurezza, la tollerabilità, la farmacocinetica e la farmacodinamica di una dose singola di lanreotide PRF in soggetti affetti da acromegalia precedentemente trattati e controllati con octreotide LAR
    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 ocreotide LAR
    Studio clinico per determinare la dose massima, la sicurezza e la tollerabilità di un'iniezione di lanreotide formulazione a rilascio prolungato precedentemente trattati con ocreotide LAR
    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 PHARMA SAS
    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 support Azienda Farmaceutica: Ipsen 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+33 1 58335000
    B.5.5Fax number+33 1 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 ACETATO
    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 ACETATO
    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 Suspension 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 ACETATO
    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
    Individuare la massima dose tollerata (MTD) e indagare la farmacocinetica (PK) di una dose singola di lanreotide PRF in soggetti affetti da 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
    - Indagare la sicurezza e la tollerabilità di una dose singola di lanreotide PRF
    - Indagare la farmacodinamica (PD) di una dose singola di lanreotide PRF
    - Indagare la PK degli eccipienti
    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 non childbearing potential or male. Non childbearing 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 octreotide LAR 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 <upper limit of normal [ULN]).
    - 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.
    Per essere arruolati nello studio, i soggetti dovranno rispondere a tutti i seguenti criteri:
    - Diagnosi documentata di acromegalia.
    - Rilascio del consenso informato scritto prima dell’avvio delle procedure correlate allo studio.
    - Età compresa tra i 18 e i 75 anni (inclusi).
    - Donne sterili e uomini. Si definisce sterile una donna entrata in fase di post menopausa da almeno 1 anno, o una donna con sterilità documentata (naturale o acquisita).
    - Qualora la relativa partner sia a rischio di gravidanza, gli uomini dovranno accettare di utilizzare un metodo anticoncezionale
    medicalmente riconosciuto ed efficace (cioè, preservativo) per tutta la durata dello studio (massimo 7 mesi).
    - Trattamento con dosi stabili di octreotide LAR durante almeno i 3 mesi immediatamente precedenti l’arruolamento nello studio, con controllo della patologia confermato durante tale periodo (valori di IGF 1 corretti per l’età <limite superiore della norma [ULN]).
    - In caso di soggetti sottoposti a trattamento per ipertensione, assunzione di dosi stabili per almeno 1 mese prima dell’arruolamento nello studio.
    - I soggetti dovranno avere l’intenzione e la capacità di rispettare le restrizioni imposte dallo studio, di restare presso il centro per il periodo richiesto durante il corso della sperimentazione e di ritornare presso il centro per le valutazioni di follow-up come specificato nel protocollo.
    E.4Principal exclusion criteria
    Subjects will not be included in the study if the subject:
    - Has undergone radiotherapy within 3 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.
    - 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.
    I soggetti non saranno arruolati nello studio qualora:
    - Siano stati sottoposti a radioterapia nell’arco dei 3 anni precedenti l’arruolamento nello studio.
    - Siano stati trattati con agonisti dopaminergici e/o con antagonisti recettoriali del GH, oppure siano stati sottoposti a chirurgia ipofisaria durante i 3 mesi precedenti l’arruolamento nello studio.
    - Si preveda che debbano essere sottoposti a chirurgia ipofisaria o a radioterapia durante il corso dello studio.
    - Presentino anomalie epatiche clinicamente significative e/o alanina aminotransferasi (ALT) e/o aspartato transaminasi (AST) ≥3 x ULN e/o fosfatasi alcalina (AP) ≥2,5 x ULN e/o bilirubina totale ≥1,5 x ULN e/o gamma-glutamil transpeptidasi (GGT) ≥2,5 x ULN
    durante il periodo di Screening (risultati del laboratorio centrale) o anamnesi di tali anomalie effettuata durante il trattamento con analoghi della somatostatina (SSTa).
    - Presentino anomalie pancreatiche clinicamente significative e/o amilasi e/o lipasi ≥1,5 x ULN durante il periodo di Screening (risultati del laboratorio centrale).
    - Presentino anomalie renali significative e/o creatinina ≥1,5 x ULN.
    - Siano affetti da diabete non controllato (emoglobina glicata [HbA1c] ≥9%, accertata dal laboratorio centrale durante il periodo di
    Screening), o da diabete trattato con insulina per meno di 6 mesi prima dell’arruolamento nello studio.
    - Siano affetti da malattie cardiovascolari note non controllate o presentino una delle seguenti condizioni durante i 6 mesi di Screening: aritmia ventricolare o atriale ≥ grado 2, bradicardia ≥ grado 2, prolungamento dell’intervallo QT corretto (QTc)
    all’elettrocardiogramma (ECG) ≥ grado 2, infarto miocardico, angina severa/instabile, insufficienza cardiaca congestizia sintomatica, ictus cerebrovascolare o attacco ischemico transitorio, embolia polmonare, ipertensione non adeguatamente controllata mediante i farmaci attualmente disponibili.
    - Facciano uso di terapia ormonale sostitutiva (HRT) con estrogeni.
    - Presentino anamnesi di calcolosi biliare o presenza di calcoli/sabbia biliare all’ecografia della cistifellea eseguita allo Screening (esame locale).
    - Presentino parametri anomali durante il periodo di Screening, altre condizioni mediche o risultati di laboratorio che, a parere del ricercatore, possano mettere a rischio la loro sicurezza.
    - Siano stati trattati con altri farmaci sperimentali (IMP) prima della prima visita di studio, senza sottoporsi a un periodo di washout di una durata pari ad almeno sette volte l’emivita di eliminazione del composto sperimentale.
    - Presentino ipersensibilità nota a uno qualsiasi dei materiali testati o dei relativi composti.
    - Durante lo studio potranno presumibilmente avere bisogno di terapie con farmaci non consentiti dal protocollo di studio.
    - Presentino anamnesi o attuali problemi noti di abuso di alcol o di droghe.
    - Presentino condizioni mentali tali da renderli incapaci di capire la natura, lo scopo e le possibili conseguenze dello studio e/o segni evidenti di attitudine non collaborativa.
    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
    Variabili relative alla sicurezza: • Eventi Avversi. • Segni vitali (pressione ematica e frequenza cardiaca in posizione supina ed eretta e temperatura corporea) • Esame fisico • ECG a 12 derivazioni e l’intervallo QT corretto (QTc) saranno calcolati mediante formula di Fridericia • Valutazioni cliniche di laboratorio: ematologia, coagulazione, biochimica clinica e urinocoltura • Emoglobina Glicosilata (HbA1c) • Velocità di filtrazione glomerulare (eGFR) stimata mediante formula MDRD (Modifica della Dieta nella Malattia Renale) • Ecografia della cistifellea • Presunti anticorpi anti-lanreotide • Valutazione delle reazioni al sito di iniezione (aspetto, sintomi topici). Variabili relative alla farmacocinetica: • Concentrazioni plasmatiche di lanreotide • Parametri PK di Lanreotide: - Ctrough - massima concentrazione plasmatica (Cmax) - tempo di picco (Tmax) - area sottesa alla curva di concentrazione plasmatica nel tempo dal momento 0 a 85 giorni (AUC0 85) - area sottesa alla curva di concentrazione plasmatica nel tempo estrapolata all’infinito (AUC0 inf.) - emivita terminale apparente (t1/2) - tempo medio di permanenza (MRT) - clearance apparente (CL/F) - volume di distribuzione apparente (V/F). • Concentrazione plasmatica degli eccipienti • Parametri PK degli eccipienti: - Cmax - Tmax - area sottesa alla curva di concentrazione plasmatica nel tempo dal tempo 0 all’ultimo intervallo quantificabile (AUCt) - AUC 0-inf - t½ - MRT - 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
    Variabili relative alla sicurezza: • Il tempo di rilevazione dipende dal tipo di variabile Concentr. plasmatiche di lanreotide• Basale (prima della somministr. di lanreotide PRF al G.1)• 1, 2, 4, 6, 8 e 12 ore dopo la somministr., il giorno del tratt.(G.1)• 24 ore dopo il tratt.(G.2)• I gg 3 e 5 e le Sett. 2, 3, 5, 9 e 13 dopo la somministr. di lanreotide PRF (il campione della Sett.13 sarà prelevato il G.85 e corrisponderà all’ultima concentr.dell’intervallo di dosaggio[Ctrough])• Alle sett. 17, 21 e 25 (o EW) durante il follow up Concentr. plasmatica degli eccipienti• Basale (prima della somministr. di lanreotide PRF del Giorno 1)•1, 2, 4, 6, 8 e 12 ore dopo il trattamento, al giorno del dosaggio (G. 1), 24 ore dopo il trattamento (G.2) e ai Gg 3 e 5 dopo la somministr. di lanreotide PRF
    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)
    Variabili relative alla farmacodinamica: • IGF 1 • Ciclo del GH (cinque intervalli di campionatura, con campioni ogni 30 minuti per 2 ore durante la mattinata) • Campionatura per il GH random • Triiodotironina libera (FT3), tiroxina libera (FT4), ormone tireostimolante (TSH) e prolattina (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: Screening, al Basale (prima del trattamento), 6 ore dopo il trattamento del Giorno 1 e alle Settimane 5, 9 e 13 e durante il follow up settimane 21 e 25/EW. • Ciclo del GH: Screening, Basale (prima del trattamento) e alle Settimane 5 e 13. • Campionatura per il GH random, 6 ore dopo il trattamento del Giorno 1, Settimana 9 e Settimana 17, 21 e 25/EW durante il follow up • FT3/FT4/TSH/PRL: Screening, Basale (prima del trattamento), Settimane 2, 5 e 13 del periodo di trattamento e settimana 25/EW durante il follow up
    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 No
    E.6.5Efficacy No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Yes
    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
    France
    Germany
    Hungary
    Italy
    Netherlands
    Romania
    Russian Federation
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days16
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 state5
    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.
    Il trattamento dopo che il soggetto avrà terminato la partecipazione allo studio sarà lasciato al giudizio dello sperimentatore.
    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 Decision2015-04-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
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