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    Summary
    EudraCT Number:2010-023513-64
    Sponsor's Protocol Code Number:GE-067-015
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-023513-64
    A.3Full title of the trial
    A Single-Arm Open-Label Multi-Center Study to Determine the Specificity of
    Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in
    Healthy Young Adult Subjects Aged 18 to 40
    A.3.2Name or abbreviated title of the trial where available
    GE-067-015
    A.4.1Sponsor's protocol code numberGE-067-015
    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 SponsorGE Healthcare Ltd and its Affiliates
    B.1.3.4CountryUnited Kingdom
    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 nameFlutemetamol (18F) Injection
    D.3.2Product code AH110690 (18F) Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN[18F]flutemetamol
    D.3.9.1CAS number 765922-62-1
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number185
    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 Yes
    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
    Healthy volunteers (the absence of brain amyloid will be studied; amyloid is present in Alzheimer's disease)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the overall specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a positron emission tomography (PET) scan by independent blinded readers reviewing images from a population of healthy young adult subjects aged 18 to 40.
    E.2.2Secondary objectives of the trial
    (1) To characterize the safety ascribed to a single dose of Flutemetamol (18F) Injection.
    (2) To determine the composite standard uptake value ratio (SUVR) following Flutemetamol (18F) Injection in a population of healthy young adults.
    (3) To determine the composite SUVR following Flutemetamol (18F) Injection by individual demographic parameter, clinical site and geographic location, and the commonly used scanners used to obtain the images in this study
    (4) To determine the specificity of Flutemetamol (18F) Injection for excluding the presence of brain amyloid based on the visual assessment of a PET scan by independent blinded readers for individual demographic parameters, PET scanning time (10 minutes vs. 30 minutes), clinical site and geographic location, and the
    commonly used scanners used to obtain the images in this study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ((1) The subject is an >18 and <40 years old.
    (2) Subject has no evidence of cognitive impairment by medical history.
    (3) The subject has a Mini-Mental State Examination (MMSE) score of >28, and
    considered to be cognitively normal per Investigator's judgment.
    (4) The subject has MRI scan as part of the screening visit of sufficient diagnostic quality and consistent with normal brain function.
    (5) The subject had at least 6 years of education or has a good work history (sufficient to exclude mental retardation).
    (6) The subject’s general health is adequate to comply with study procedures, as
    ascertained by review of their medical history, and laboratory and physical examinations, which must have been performed within 45 days before administration of Flutemetamol (18F) Injection.
    (7) For women who are either surgically sterile (have had a documented bilateral
    oophorectomy and/or documented hysterectomy) or are postmenopausal (cessation of menses for more than 3 years), enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine human chorionic gonadotropin pregnancy test (with the result known on the day of and before IMP administration) must be negative.
    (8) Informed consent is signed and dated by the subject in accordance with local
    regulations.
    (9) The subject is willing and able to participate in all study procedures.
    E.4Principal exclusion criteria
    (1) The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT) or participated in any other clinical study within 30 days of study entry.
    (2) The subject has known allergies to Flutemetamol (18F) Injection or to any of the
    constituents.
    (3) The subject is pregnant or breast-feeding.
    (4) The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
    (5) The subject has a contraindication for MRI (including, but not limited to,
    claustrophobia, pacemaker, and presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
    (6) The subject has a history of head injury with loss of consciousness.
    (7) The subject has any clinically significant medical, psychiatric or neurological condition or any clinically significant abnormality on physical, neurological or laboratory examination that might be associated with brain pathology, as determined by the Investigator.
    (8) The subject has a family history of AD (more than 1 first degree relative [i.e. birth
    parents and siblings] with diagnosis of AD).
    (9) The subject is undergoing monitoring of occupational ionizing radiation exposure.
    (10) The subject has a history of HIV infection or hepatitis.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the visual assessment of the individual PET images
    classified as normal or abnormal for the presence of amyloid based on independent blinded reads using 3 blinded independent readers.
    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 No
    E.6.7Pharmacodynamic No
    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
    to determine specificity for excluding brain amyloid
    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) 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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    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
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 300
    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 Decision2010-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-26
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