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    Summary
    EudraCT Number:2007-006115-23
    Sponsor's Protocol Code Number:BCBe/07/Neb-Space/102
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2007-006115-23
    A.3Full title of the trial
    Effects of nebivolol on the cardiovascular functions, thermoregulation and blood flow during real and simulated conditions of microgravity
    A.3.2Name or abbreviated title of the trial where available
    MISSION Medicine In Space Study - Investigation Of Nebivolol
    A.4.1Sponsor's protocol code numberBCBe/07/Neb-Space/102
    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 SponsorBerlin-Chemie AG
    B.1.3.4CountryGermany
    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 Yes
    D.2.1.1.1Trade name Nebilet
    D.2.1.1.2Name of the Marketing Authorisation holderBerlin-Chemie AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNebilet
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNNebivolol
    D.3.9.1CAS number 118457-14-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Effects on the cardiovascular functions, thermoregulation and blood flow during microgravity

    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall aim of the study is to generate first data about the options to use a beta-blocker in space in order to make some recommendations for a Space Pharmacopoeia.
    The primary objective is to investigate possible influences of nebivolol on intra-individual changes of microcirculation measured on temple and shinbone (tibia) under simulated and real micro-g conditions.
    E.2.2Secondary objectives of the trial
    Influences of nebivolol on heart rate, blood pressure, ECG and facial heat distribution. Moreover a standard model for drug testing under micro-g conditions will be investigated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent
    2. Male or female
    3. Age 20 - 45 years
    4. The subject is healthy as judged by the responsible physician, with no clinically significant abnormality identified during the screening evaluation or medical history, including ECG
    5. Non-smoker
    6. The subject is willing and able to participate in both study parts (tilting-table part and parabolic flight part)
    7. Positive standard medical check-up for parabolic flight
    8. The subject has a normal cardiovascular adjustment during tilting-table tests
    9. The subject is willing to restrain a normal fluid supply before the tilting-table tests without a subjective feeling of thirst
    10. The subject is able and willing to understand and comply with the requirements, restrictions and instructions defined in the trial protocol
    E.4Principal exclusion criteria
    1. The subject has a concomitant illness and/or nebivolol and/or scopolamine specific contraindications apply:
    - Liver insufficiency or liver function impairment
    - Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy
    - Sick sinus syndrome, including sino-atrial block
    - Second and third degree heart block
    - History of bronchospasm and bronchial asthma
    - Untreated phaeochromocytoma
    - Metabolic acidosis
    - Bradycardia (heart rate < 60 bpm prior to start of treatment)
    - Hypotension (systolic blood pressure < 90 mmHg)
    - Severe peripheral circulatory disturbances
    - Narrow-angle glaucoma
    - Prostatic hypertrophy in male subjects
    - Pyloric obstruction

    2. Known idiosyncrasy (hypersensitivity) to nebivolol and/or scopolamine or to any of the ingredients of the study drugs, or any known hypersensitivity to beta-blocker and/or anti-cholinergic drugs

    3. Known motion sickness

    4. Known fear of flying and/or abnormal nervousness

    5. The subject is participating or has participated within the previous three months in a clinical study with an investigational or a non-investigational drug or device

    6. The subject has participated in more than three studies within the past year

    7. The subject is using any prescription or non-prescription drugs, vitamins, herbal and dietary supplements (including St John's Wort) within seven days or five half lives (which-ever is the longer) prior to the first dose of study medication

    8. Clinically relevant symptoms within seven days prior to start of study

    9. Any condition (surgical or medical) which will affect absorp-tion, distribution, metabolism and/or excretion of the study drug

    10. Need for continuous medical treatment within seven days or five half lives (whichever is longer) prior to or during the study with the exception of contraceptives and scopolamine for prevention of motion sickness

    11. History or presence of alcohol or substance abuse

    12. Alcohol intake 24 hours prior to or during study visits

    13. Regular consumption of large amounts of caffeine-containing beverages (equivalent to more than six cups of coffee per day)

    14. Pregnancy or lactation

    15. Female subjects not willing to use appropriate contraceptive measures for the duration of the study and for at least one month after the last dose of study drug. Medically accept-able contraceptives include e.g.: (1) surgical sterilization, (2) approved hormonal contraceptives, (3) 3-months injection, (4) combined oral methods (combination of methods with a gel, spray, foam, salve or suppository), (5) some kind of loop. Sexual abstinence or vasectomy of the partner are also acceptable measures to avoid pregnancy

    16. The subject has been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
    E.5 End points
    E.5.1Primary end point(s)
    Intra-individual changes of microcirculation under nebivolol or placebo.
    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 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
    Effects of nebivolol on the cardiovascular functions, thermoregulation and blood flow under micro-g
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Tilting-table part: cross over; parabolic flight part: open (no placebo)
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    For administrative and safety reporting purposes, the end of the clinical trial will be defined as the date of final report signature by all parties (please see study protocol section 9.5.9)
    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 months
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial months4
    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 Yes
    F.3.2Patients No
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 16
    F.4.2.2In the whole clinical trial 16
    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)
    After completion of his/her study participation, no treatment is planned as the participants are healthy volunteers.
    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 Decision2008-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-18
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