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    Summary
    EudraCT Number:2008-001209-41
    Sponsor's Protocol Code Number:AC-060A201
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-05-30
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-001209-41
    A.3Full title of the trial
    A multi-center, double-blind, placebo-controlled, randomized, multiple dose, 2-period cross-over, Phase IIa study to investigate the pharmacodynamics, tolerability and safety, and pharmacokinetics of ACT 129968 in subjects with mild to moderate allergic asthma
    A.4.1Sponsor's protocol code numberAC-060A201
    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 SponsorActelion Pharmaceuticals Ltd
    B.1.3.4CountrySwitzerland
    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 nameACT-129968
    D.3.2Product code ACT-129968
    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 codeACT-129968
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 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
    Allergic 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 10001705
    E.1.2Term Allergic 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 demonstrate the effect of ACT-129968 vs. placebo on forced expiratory volume, measured in 1 second (FEV1) during the late allergic reaction (3–10 hours) after a bronchial allergen challenge.
    E.2.2Secondary objectives of the trial
    • To investigate the effect of ACT-129968 on airway inflammation and airway hyperresponsiveness (AHR) after a bronchial allergen challenge.
    • To investigate the tolerability and safety of ACT-129968.
    • To investigate the pharmacokinetics (PK) of ACT-129968 in subjects with mild to moderate allergic asthma.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Men and women not of childbearing potential 18–55 years of age (inclusive).
    -Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile.
    •Signed informed consent prior to any study-mandated procedure.
    •Having stable, mild to moderate allergic asthma for at least 1 year and fulfilling all of the following criteria at screening (all assessments should be performed within a period of 1 week):
    –No ongoing or recent treatment (see definition below) for allergic airway disease (prescribed or over-the-counter [OTC]) other than stable use of short-acting, inhaled beta2 agonist as needed.
    –Asymptomatic hay fever at screening, which is expected to remain asymptomatic during the study.
    –No hospital admissions for asthma in the previous year.
    –FEV1 >= 70% of predicted value at both of the screening visits, measured >= 8h after any use of a short-acting inhaled beta2 agonist.
    –Airway hyperresponsiveness to inhaled methacholine (Mch) with the provocative concentration of Mch causing a fall in baseline FEV1 of 20% (PC20FEV1) (Mch) < 16 mg/mL Mch chloride.
    –Early and late allergic reaction (EAR, LAR) airway response with >= 15% minimal reduction in FEV1 during LAR (3–10h) following a standardized bronchial allergen challenge with house dust mite (HDM) extract.
    • Positive skin prick test (wheal diameter >= 3 mm) to HDM extract within 1 year before screening.
    • Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) at screening.
    • Systolic blood pressure (SBP): 100–150 mmHg, diastolic blood pressure (DBP): 50–90 mmHg and heart rate (HR): 40–90 bpm (all inclusive) after 5 minutes in the supine position at screening.
    • 12-lead electrocardiogram (ECG) without clinically relevant abnormalities at screening.
    • Hematology, biochemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
    • Negative results from drug screen (amphetamines, cocaine, cannabinoids, opiates, benzodiazepines, cotinine) at screening.
    • Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study.
    E.4Principal exclusion criteria
    • Ongoing or recent (see below) treatment with medications for allergic airway disease (either prescribed or OTC) other than short-acting, inhaled beta2 agonist.
    • Recent treatment for the following medications is defined as:
    – Systemic corticosteroids: within 8 weeks prior to screening.
    – Inhaled corticosteroids: within 4 weeks prior to screening.
    – Intranasal corticosteroids: within 4 weeks prior to screening.
    – Leukotriene receptor antagonists: within 2 weeks prior to screening.
    – Cromoglycate: within 2 weeks prior to screening.
    – Theophylline: within 1 week prior to screening.
    – Anti-histamines: within 1 week prior to screening.
    – Long-acting beta2 agonists: within 1 week prior to screening.
    – Anti-cholinergics: within 1 week prior to screening.
    – Anti-immunoglobulin E (IgE): within 6 months prior to screening.
    – Immunotherapy: any previous use.
    – Other medications: at the discretion of the investigator and with the sponsor’s consent.
    • Smoking within the last year or life-time consumption > 10 pack-years
    • Symptoms of a clinically relevant lower respiratory tract infection in the 3-week period prior to screening.
    • Diagnosis of aspirin or non-steroidal anti-inflammatory drug (NSAID)-induced asthma.
    • Planned treatment or treatment with another investigational drug within 3 months prior to screening.
    • Loss of 250 mL or more of blood within 3 months before the screening examination.
    • Positive HIV serology.
    • History of hepatitis B or C and/or positive hepatitis serology, indicating acute or chronic hepatitis B or C.
    • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to the screening examination.
    • History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with treatment compliance, study conduct or interpretation, such as any unstable medical abnormality or a disease which could affect the absorption, distribution, metabolism, or excretion of the study drug.
    • Known hypersensitivity to any excipients of the study drug formulation.
    • Any clinically relevant drug or food allergy.
    • Legal incapacity or limited legal capacity at screening.
    E.5 End points
    E.5.1Primary end point(s)
    • To demonstrate the effect of ACT-129968 vs. placebo on FEV1 during the late allergic reaction (3–10 hours) after a bronchial 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 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
    Tolerabililty
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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 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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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 Decision2008-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-15
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