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    Summary
    EudraCT Number:2008-001061-29
    Sponsor's Protocol Code Number:NN8630-1823
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-29
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-001061-29
    A.3Full title of the trial
    A randomised, double blind, placebo-controlled, multiple dose, dose-escalating, sequential dose group trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of pegylated long-acting human growth hormone (NNC126-0083) in Growth Hormone deficient adults (AGHD)
    A.4.1Sponsor's protocol code numberNN8630-1823
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 nameNN8630
    D.3.2Product code NNC 126-0083
    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 IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeNNC 126-0083
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6,8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant growth hormone
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Growth hormone deficiency
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    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 safety and tolerability of ascending multiple subcutaneous (sc) doses of NNC126-0083 in AGHD male and female subjects compared to placebo.
    E.2.2Secondary objectives of the trial
    To determine pharmacokinetics (PK) and pharmacodynamics (PD) of ascending multiple sc doses of NNC126-0083 in AGHD male and female subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
    2. AGHD male or female subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II1
    3. On GH replacement therapy > 3 months
    4. Body Mass Index (BMI, kg/m^2) of 18.5 to 35.0 kg/m^2, both inclusive
    5. Age ≥20 and ≤ 65 years

    All subjects will be required to discontinue GH replacement treatment 2 weeks before first NNC126-0083 administration.

    Fertile AGHD females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion. (The Danish Medicines Agency usually finds that contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices and transdermal patches are safe contraceptive methods in connection with medicinal product trials). Fertile femals included in the trial must thus use one of the above-mentioned contraceptive methods together with a barrier method during the entire treatment period and for a period of at least 5 weeks after last visit.
    E.4Principal exclusion criteria
    1. Participation in any other clinical trial involving any investigational products within the last three months prior to this trial
    2. Previous participation in this trial (randomised)
    3. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (e.g. barrier method plus contraceptive pills, intrauterine devices, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices or transdermal patches) for the duration of the study
    4. Malignant disease
    5. Hypophysectomy due to gigantism
    6. Proliferative retinopathy judged by retina-photo within the last year – only with concomitant diabetes
    7. Heart insufficiency, NYHA class >2
    8. HbA1_C>8.0% - Poorly controlled patients with diabetes mellitus
    9.Insulin-treated diabetes mellitus subjects
    10. Stable pituitary replacement therapy for less than 3 months
    11. Impaired liver function, defined as alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times upper normal range
    12. Impaired renal function, defines as s-creatinnine ≥135 µmol/L (=1.5 mg/dL) for males and ≥ 110 µmol/L (=1.3 mg/dL) for females
    13. Known or suspected allergy to the trial product or related products
    14. History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
    15. Clinically significant illness within 4 weeks of dosing
    16. Any clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
    17. Active hepatitis B, measured by surface antigen B (HbsAg) and/or active hepatitis C, measured by positive hepatitis C virus antibody test
    18. Positive result of test for human immunodeficiency virus (HIV) antibodies
    19. Clinically significant abnormal ECG at screening as evaluated by Investigator
    20. Use of any non-prescribed systemic or topical medication except routine vitamins, within 2 weeks prior to dosing. Occasional use of acetylsalicylic acid and paracetamol is permitted
    21. Donation of blood or plasma in the past month or in excess of 500 ml within the 12 weeks preceding screening
    22. Surgery or trauma with significant blood loss within the last 3 months prior to dosing.
    23. A significant history of alcoholism or drug/chemical abuse, or who consumes more than 28 units of alcohol per week (one unit of alcohol equals about 250 ml of beer or lager, 1 glass of wine, or 20 ml of spirits)
    24. Mental incapacity or language barriers which preclude adequate understanding or cooperation, who are unwilling to participate in the trial or who in the opinion of their general practitioner or the Investigator should not participate in the trial
    25. Strenuous exercise during the trial
    26. Any condition interfering with trial participation or evaluation or that may be hazardous to the subject
    E.5 End points
    E.5.1Primary end point(s)
    Safety and Tolerability Parameters after four doses of NNC126-0083: Physical examination, body weight, vital signs and ECG, clinical laboratory tests (haematology, biochemistry, urinalysis, fasting glucose, fasting insulin), NNC126-0083 antibodies, Adverse Events (AE’s) including injection site reactions.
    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 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
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    multi dose
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 No
    E.8.5.1Number of sites anticipated in the EEA3
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days22
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 32
    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 Decision2008-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
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