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    Summary
    EudraCT Number:2008-001714-24
    Sponsor's Protocol Code Number:BTA798-CL2-001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-28
    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 number2008-001714-24
    A.3Full title of the trial
    A Phase II, Double-Blind Placebo-Controlled Study to Determine the Prophylactic Efficacy of Oral BTA798 in an Experimental Rhinovirus Challenge Model
    A.4.1Sponsor's protocol code numberBTA798-CL2-001
    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 SponsorBiota Scientific Management Pty Ltd
    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 nameBTA798
    D.3.2Product code BTA798
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeBTA798
    D.3.9.3Other descriptive name3-Ethoxy-6-{2-[1-(6-methylpyridazin-3-yl)piperidin-4-yl]ethoxy}-benzo[d]iso-xazole phosphoric acid 1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25, 100, 200
    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 placeboCapsule, hard
    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
    BTA798 is an investigational drug being developed as a potential agent for treatment and prevention of the common cold.
    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
    1) To evaluate the efficacy of BTA798 in preventing HRV infection

    2) To evaluate the efficacy of BTA798 in preventing upper respiratory tract illness.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of BTA798 in reducing the severity of HRV infection,
    namely:
    - Upper respiratory tract symptom score;
    - Mucus production;
    - Duration of infection.
    • To evaluate the effect of BTA798 on virological endpoints, namely:
    - Total Viral Load days 1-5;
    - Peak Viral titre;
    - Daily viral titre.
    • To evaluate the effect of BTA798 on other clinical symptoms and signs;
    • To assess safety and tolerability of BTA798;
    • To evaluate plasma pharmacokinetics of BTA798 during HRV infection in a
    random subset of the study population;
    • To assess, at a future point, the potential for emergence of resistance to
    BTA798.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A subject will be considered eligible for inclusion in this clinical trial only if all of the
    following criteria apply:
    1. Males between the age 18 to 45 years, inclusive;
    2. Body Mass Index between 18 and 33 kg/m2 inclusive;
    3. Comprehension of the study requirements; availability for the required study
    period, ability to attend scheduled study visits, and willingness to participate in
    the quarantine challenge phase;
    4. Subjects will have given their written informed consent to participate in the study
    and to abide by the study restrictions;
    5. Good general health status as determined by medical history, physical
    examination including vital signs, 12-lead ECG and clinical laboratory tests, and
    with no disease that the Investigator regards as clinically relevant;
    6. Agreement to use a double-barrier method (condom/spermizide) as a method of
    birth control for any sexual contact for 90 days after the end of quarantine phase;
    7. Normal lung function tests as defined by a forced expiratory volume in 1 second
    (FEV1) greater than 80% of predicted for age, gender, ethnicity and height and a
    forced expiratory ratio (FER) (FER= FEV1/FVC) greater than or equal to 80%;
    8. Able to tolerate nasal wash procedure;
    9. No detectable levels of HRV neutralising antibodies;
    10. Negative results in HIV antibody, HBsAg and Hepatitis C antibody tests;
    11. Willingness to abstain from alcohol and caffeine-containing food and beverages
    for 48 hours prior to dosing and for the duration of the clinical trial.
    E.4Principal exclusion criteria
    1. Presence of household member or close contact (for an additional two weeks after
    the discharge from the isolation facility) who is:
    a. less than 3 years of age;
    b. any person with any know immunodeficiency;
    c. any person receiving immunosuppressant medications;
    d. any person undergoing or soon to undergo cancer chemotherapy within 28
    days of challenge;
    e. any person who has diagnosed emphysema, asthma or COPD, is elderly
    residing in a nursing home, or with severe lung disease; or
    f. any person who has received a transplant (bone marrow or solid organ).
    2. Health care workers (including doctors, nurses, medical students and allied
    healthcare professionals) anticipated to have patient contact within two weeks of
    the viral challenge. Healthcare workers who volunteer should not work withpatients until 14 days after discharge or until their symptoms are fully resolved (whichever is the longer);
    3. History of seasonal hay fever or a seasonal allergic rhinitis (SAR), including the
    use of symptomatic only medication and non prescription medication.
    4. Chronic use (more than once a week in any two [2] of the four [4] weeks
    preceding the first BTA798 dose) of any medication or other product (prescription
    or over-the-counter), for symptoms of rhinitis or nasal congestion or any chronic
    nasopharyngeal complaint, or chronic use of any intranasal medication for any
    indication;
    5. Acute use of any medication or other product, prescription or over-the-counter,
    for symptoms of rhinitis or nasal congestion within seven (7) days prior to the
    first BTA798 dose;
    6. Use of any prescription medication during the fourteen days prior to dosing;
    7. Subjects who have received any medications known to chronically alter drug
    absorption or elimination processes within 30 days of the first dose
    administration;
    8. Subjects who are current smokers or have been non-smokers for less than 6
    months prior to dosing, or have a cumulative smoking history of 10 or more pack
    years;
    9. Subjects who are unwilling to desist from smoking from the first study visit to the
    final follow-up visit, as evidenced by a positive urine cotinine test at first study
    visit, and at quarantine entry;
    10. Receipt of any investigational HRV vaccine within six (6) months prior to
    challenge, or prior participation in a clinical trial of any investigational vaccine or
    experimental viral challenge delivered to the respiratory tract within one (1) year
    prior to challenge;
    11. Presence of any febrile illness or symptoms suggestive of upper respiratory tract
    infection between admission for virus challenge and administration of the
    challenge inoculum;
    12. History of epistaxis;
    13. History or clinical evidence of significant respiratory disease (including asthma,
    chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF) and/or
    recurrent lower respiratory tract infection at any time, or upper respiratory tract
    infection within the last month, or lower respiratory tract infection within the last
    three months;
    14. History or clinical evidence of significant cerebrovascular, cardiovascular,
    gastrointestinal, or haematological disease, or myocardial infarction, or a
    previous history of any other underlying disease (including immunocompromised
    subjects and/or neutropenic subjects) that, in the opinion of the Investigator
    would interfere with subject safety or the conduct of the clinical trial;
    15. History or clinical evidence of renal disease (including renovascular occlusive
    disease), nephrectomy and/or renal transplant, and/or previous clinically
    significant laboratory abnormalities of renal function parameters. All subjects
    with serum creatinine or proteinuria outside the normal laboratory reference
    range at screening and baseline that are regarded by the Investigator as clinically
    significant;
    16. History or clinical evidence of hepatic disease and/or previous clinically significant
    laboratory abnormalities of liver function parameters. All subjects with bilirubin,
    gamma glutamyl transferase (GGT), alanine transaminase (ALT), and aspartatetransaminase (AST) outside the normal laboratory reference range at screening and baseline that are regarded by the Investigator as clinically significant;
    17. Subjects with a history of adverse reactions to heparin or any components of the
    IP and challenge virus preparation;
    18. History of alcohol and/or class A drug abuse within 1 year prior to screening
    (verified by drug screening);
    19. Receipt of blood or blood products, or loss of 450 mL or more of blood, during the
    last three months prior to dosing.
    20. Employees or immediate relative of those employed at Retroscreen Virology.
    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of BTA798 will be assessed in terms of:
    • Incidence of HRV infection as measured by positive quantitative viral culture
    from nasal wash.
    • Incidence of upper respiratory tract illness (see Section 8 for definition).

    Additional efficacy and safety data will be assessed in terms of:
    • Group mean viral load as measured by AUC of log10 viral titre versus time
    (inoculation to day 5) and quantitative PCR;
    • Group mean total symptom score in infected participants;
    • Daily group mean viral titre (to day 7);
    • Comparison of individual symptoms;
    - Self-assessed total upper respiratory tract infection scores;
    - Group mean systemic illness scores;
    - Group mean physician scores;
    - Group mean combined physician and patient-reported scores for upper
    respiratory tract infection;
    • Mucus weights from nasal discharge;
    • Safety;
    • Plasma pharmacokinetics of BTA798 during multiple dosing in a subgroup of
    subjects;
    • Immunological response to inoculation.
    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 Yes
    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 No
    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 Yes
    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 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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    Last visit of the last subject.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial months7
    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 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 No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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 Decision2008-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-06-10
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