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    Summary
    EudraCT Number:2008-000500-83
    Sponsor's Protocol Code Number:2-55-52060-002
    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:2008-09-26
    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 number2008-000500-83
    A.3Full title of the trial
    A PHASE II EXPLORATORY, ASCENDING DOSE, MULTICENTRE STUDY TO
    INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY AND
    TOLERABILITY, OF BIM 23A760 IN ACROMEGALIC PATIENTS.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code number2-55-52060-002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBEAUFOUR IPSEN PHARMA
    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
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBIM23A760
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 868562-36-1
    D.3.9.2Current sponsor codeBIM23A760
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10000599
    E.1.2Term Acromegaly
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the pharmacodynamics (PD) of BIM 23A760,
    administered by single subcutaneous (s.c.) injection to
    acromegalic patients.
    E.2.2Secondary objectives of the trial
    To investigate the pharmacokinetics (PK), safety and
    tolerability of BIM 23A760, administered by single s.c.
    injection to acromegalic patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The patient has provided written informed consent prior to any
    study related procedures.
    2. The patient age is between 18 and 75 years inclusive.
    3. The patient is male, or a woman aged over 60 who has been
    post menopausal for at least 5 years. In addition women with a
    documented infertility (natural or acquired) may be included.
    4. The patient must agree that, if their partner is at risk of
    becoming pregnant, they will use an effective method of
    contraception as defined in the ICH M3 guideline, and this
    should be continued for two months after the Investigational
    Medicinal Product (IMP) administration.
    5. The patient must have documentation supporting the diagnosis
    of acromegaly, including elevated GH and/or insulin-like
    growth factor - I (IGF-I) levels.
    6. The patient has a mean serum GH concentration > 4µg/l during
    a 5h profile and an IGF-I serum level above normal during the
    screening period.
    E.4Principal exclusion criteria
    1. The patient has undergone pituitary surgery within 3 months
    prior to study entry.
    2. The patient has undergone radiotherapy anytime prior to study
    entry.
    3. It is anticipated that the patient will receive pituitary surgery
    or radiotherapy during the study.
    4. The patient has received long acting somatostatin analogues
    within 6 months prior to study entry.
    5. The patient has received dopamine agonist or short acting
    octreotide within 1 month before entering the study.
    6. The patient has received GH antagonist at anytime prior to
    study entry.
    7. The patient is known for not being controlled by somatostatin
    analogues at anytime prior to study entry.
    8. The patient has any known uncontrolled cardiovascular
    disease and/or concomitant medication(s) associated with risk
    of severe hypotension.
    9. The patient has any known valvular disease.
    10. The patient has any known uncontrolled metabolic disease.
    11. The patient has insulin-treated diabetes or HbA1c > 7.5%.
    12. The patient has clinically significant hepatic abnormalities
    and/or AST/ALT > 3 ULN during the screening period.
    13. The patient has any severe renal or hepatic insufficiency.
    14. The patient is receiving any Hormone Replacement Therapy
    (HRT).
    15. The patient is receiving neuroleptic antipsychotic/antiemetic
    drugs.
    16. The patient 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
    patient’s safety.
    17. The patient has been treated with any other IMP prior to the
    first study visit without undergoing a wash-out period of 7
    times the elimination half-life of the investigational
    compound.
    18. The patient has a known hypersensitivity to any of the test
    materials or related compounds.
    19. The patient is likely to require treatment during the study with
    drugs that are not permitted by the study protocol.
    20. The patient has a history of, or known current, problems with
    alcohol or drug abuse.
    21. The patient has any mental condition rendering the patient
    unable to understand the nature, scope and possible
    consequences of the study, and/or evidence of an
    uncooperative attitude.
    E.5 End points
    E.5.1Primary end point(s)
    PD response: Maximum observed % inhibition of GH.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic 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 Yes
    E.6.13.1Other scope of the trial description
    tollerabilita'
    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 No
    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 Yes
    E.8.1.7.1Other trial design description
    studio in aperto
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    studio di farmacocinetica e farmacodinamica
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Lo studio sara' considerato concluso alla fine della visita dell'ultimo paziente nell'ultima coorte. The study will be considered to have finished at the end of the study visit of the last patient in the last cohort.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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 Decision2008-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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