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    Summary
    EudraCT Number:2007-000017-11
    Sponsor's Protocol Code Number:OC000459/007/06
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-02-08
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-000017-11
    A.3Full title of the trial
    A study of the effects of OC000459 on responses to allergen challenge in the Vienna Chamber in subjects known to suffer from grass pollen induced allergic rhinitis: A randomised, double blind placebo controlled, two way crossover evaluation of a dose schedule of 200 mg given twice daily orally for eight days in male subjects
    A.4.1Sponsor's protocol code numberOC000459/007/06
    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 SponsorOxagen 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 nameOC000459
    D.3.2Product code OC000459
    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 codeOC000459
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    history of symptoms of grass pollen related allergic rhinitis within the previous two years
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001726
    E.1.2Term Allergic rhinitis due to pollen
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ·To assess the efficacy of OC000459 200 mg twice daily orally in comparison to placebo when subjects are challenged in the Vienna Challenge Chamber for 6 hours.
    E.2.2Secondary objectives of the trial
    ·To assess the safety of this treatment schedule in male subjects with allergic rhinitis.
    ·To assess plasma levels of OC000459 at the time of allergen challenge.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males aged 18 to 50 years with a history of symptoms of grass pollen related allergic rhinitis within the previous two years.
    2. Subjects must be free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations.
    3. FEV1 within normal limits (≥90% of predicted).
    4. Atopy defined by a positive cutaneous response (wheal ≥ 3mm compared to negative control) to mixed grass pollen within the last 12 months or at screening.
    5. Asymptomatic at screening as characterized by:
    a. Normal appearing nasal mucosa with no active allergic rhinitis.
    b. A total nasal symptom score sheet on study entry so that subjects produce a score of <2 at screening and on Day 1 of treatment periods 1 and 2.
    6. Non smokers for at least the past 12 months with a pack history ≤ 1 pack years (Pack years = (No of cigarettes smoked/day/20) x No of years smoked).
    7. A total nasal symptom score of at least 6 after challenge with ≥1400 grass pollen grains/m³ after 2 hours in the Vienna Challenge Chamber at the screening visit
    8. A positive Radio Allergen Sorbent Test (≥ class 2) for grass pollen at the screening visit or in the previous 12 months.
    9. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    10. Available to complete the study.
    11. Subjects with a negative urinary drugs of abuse screen, determined at screening
    12. Negative carbon monoxide test (smokerlyzer) or urinary cotinine test determined at screening
    13. Negative alcohol breath test determined at screening
    14. Subjects with a normal 12-lead electrocardiogram (ECG), determined at screening.
    15. Negative test for HIV and Hepatitis B and C determined at screening.
    E.4Principal exclusion criteria
    1. Medical conditions likely to affect the outcome of the study.
    2. Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforations, nasal polyps, sinus disease, chronic nasal obstruction, or other nasal diseases.
    3. Presence of any respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function (defined as FEV1 ≥ 90% predicted for height and age).
    4. Immunotherapy treatment course including inhaled or local corticosteroids in the past 28 days.
    5. Any infirmity, disability, or geographic location which, in the opinion of the principal investigator, would limit compliance with the protocol.
    6. Infection of the upper airways/lower airways, sinus, or ear, including viral infections in the 14 days prior to screening and at the start of each treatment period.
    7. Clinically significant abnormality in clinical laboratory tests at screening as determined by the principal investigator.
    8. The subject has participated in a study with a new molecular entity during the previous four months or any other trial during the previous three months.
    9. The subject regularly, or on average, drinks more than four units of alcohol per day.
    10. A history of gastrointestinal disorder likely to influence drug absorption.
    11. Receipt of prescribed or over the counter medication within 14 days of the first study day and for the duration of the trial, including vitamins and herbal remedies.
    12. Inability to communicate well with the investigator (i.e., language problem, poor mental development or impaired cerebral function).
    13. Donation of 450 ml or more blood within the previous 12 weeks.
    14. A history of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
    15. Subjects known to have tuberculosis.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy will be assessed as follows:

    Primary efficacy endpoint:
    Total nasal symptom score on Day 8

    Secondary efficacy endpoints:
    Total nasal symptom score on Day 2
    Individual components of total nasal symptom score, Eye symptom score, Other symptom score, secretion weight, rhinomanometry and nasal endoscopy parameters on Day 2 and Day 8

    Safety will be assessed as follows:
    Adverse events, clinical pathology (haematology and clinical chemistry) parameters, FEV1 and vital signs.
    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 No
    E.8.1.6Cross over Yes
    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.8.6 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 Information not present in EudraCT
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months2
    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 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 state40
    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 Decision2007-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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