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    Summary
    EudraCT Number:2008-004152-71
    Sponsor's Protocol Code Number:ICA 17043-17
    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:2008-07-25
    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 number2008-004152-71
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of TWO Weeks of Oral Senicapoc Administration on Allergen challenge in Atopic Asthmatic Subjects.
    A.4.1Sponsor's protocol code numberICA 17043-17
    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 SponsorIcagen, Inc.
    B.1.3.4CountryUnited States
    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 name Senicapoc 10mg
    D.3.2Product code ICA-17043
    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.3.9.1CAS number 289656-45-7
    D.3.9.2Current sponsor codeICA 17043
    D.3.9.3Other descriptive nameBis(4-fluorophenyl)phenyl acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    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
    Asthma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    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 safety and tolerability of multiple doses of senicapoc following oral administration to atopic asthma subjects;
    To characterize the effects of 14 days of senicapoc dosing on lung function response to allergen challenge and airway hyper-responsiveness to methacholine;
    To characterize the effects of 14 days of senicapoc dosing on changes in sputum inflammatory cell and cytokine profiles; and
    E.2.2Secondary objectives of the trial
    To characterize the senicapoc plasma concentrations in atopic asthma subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male, or female practicing acceptable contraceptive methods of 18 to 65;
    Having a history of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma);
    Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) ≥70% of predicted;
    Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests (based upon the Investigator’s overall evaluation);
    Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen (within 12 months prior to Screening Visit 1);
    A positive inhaled methacholine challenge with a PC20 ≤ 8 mg/mL (within 6 months prior to Screening Visit 1);
    Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen;
    Non-smoker (refrained from any tobacco usage or any products containing nicotine for 6 months prior to Screening Visit 1);
    Able and willing to give written informed consent to participate in the study.
    E.4Principal exclusion criteria
    Any subject who has experienced any allergic reaction to a drug which, in the opinion of the investigator, suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
    Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
    Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
    Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
    Considering or scheduled to undergo any surgical procedure during the duration of the study;
    History of alcohol and/or drug abuse within 2 years prior to Screening Visit 1;
    Donation of blood (>450 mL) or significant loss of blood within 56 days prior to Screening Visit 1;
    Received any commercially licensed investigational product within 30 days prior to Screening Visit 1 or received any unlicensed investigational product within 90 days prior to Screening Visit 1;
    History of chronic hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies;
    A positive qualitative urine drug test, a positive urine or breath alcohol test, or a positive urine cotinine or CO breath test at the first Screening visit or on Day 1;
    Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zilueton, or anti-cholinergic agents within the 28 days prior to the first Screening visit;
    Use of oral antihistamines within 1 week prior to the first Screening visit;
    Symptomatic with hay fever during any of the Screening Visits or Day 1;
    A >10 pack year cigarette history.

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a comparison of active vs. placebo in late asthmatic response to allergen challenge (LAR; 4 to 10 hours after allergen challenge).
    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 Information not present in EudraCT
    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 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 concerned2
    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 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2008-07-25. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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 Decision2008-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-24
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