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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-004584-22
    Sponsor's Protocol Code Number:D0520C00003
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2007-10-16
    Trial 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 number2007-004584-22
    A.3Full title of the trial
    A Randomised, Double-Blind, Placebo-Controlled, Two-Way Crossover Study in Healthy Volunteers to Investigate the Effect of Oral Dosing with AZD9668 on Airway Inflammation as Assessed in Induced Sputum after Challenge with Inhaled Lipopolysaccharide (LPS)
    A.4.1Sponsor's protocol code numberD0520C00003
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 nameAZD9668 tosylate
    D.3.2Product code AZD9668
    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 INNnone
    D.3.9.1CAS number none
    D.3.9.2Current sponsor codeAZD9668
    D.3.9.3Other descriptive namenone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1, 10 & 30
    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
    Chronic Obstructive Pulmonary Disease (COPD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to investigate the effect of AZD9668 compared to placebo treatment on neutrophil numbers and NE activity in induced sputum after administration of inhaled LPS.
    E.2.2Secondary objectives of the trial
    (1) To investigate the effect of oral AZD9668 compared to placebo treatment on other inflammatory markers (IL-6, IL-1beta, IL-8, TNFa, MPO activity, LTB4) in induced sputum after challenge with inhaled Lipopolysaccharide (LPS)
    (2) To measure the concentration of AZD9668 in plasma and induced sputum after challenge with inhaled Lipopolysaccharide (LPS) following oral administration
    (3) To generate additional safety and tolerability data for AZD9668
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent
    2. Healthy male or female of non-childbearing potential (defined as cessation of regular menses for more than 12 months and an FSH of >20 IU/L or surgically sterile).
    3. Aged 18-50 years inclusive.
    4. Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and minimum body weight of 50 kg.
    5. Have a normal physical examination, laboratory values, 12-lead ECG and vital signs (blood pressure and pulse), unless the investigator considers an abnormality to be clinically irrelevant.
    6. Be non-smokers, or ex-smokers who have not smoked (or used any other nicotine products) in the 12 months preceding Visit 1 with a pack-year history of less than 10.
    7. Demonstrate an FEV1 ≥80% of their predicted normal.
    8. Demonstrate no evidence of airway obstruction by having an FEV1/FVC ratio >70%.
    9. Have normal airway responsiveness to inhaled methacholine with a PC20 ≥16 mg/mL.
    10. Have negative screens for serum Hepatitis B surface antigen, Hepatitis C antibodies and HIV.
    11. Be able to produce a minimum of 200 μL sputum volume after induction with inhaled hypertonic saline.
    12. Have a sputum eosinophilia ≤2% and a sputum neutrophilia ≤80%.

    Pharmacognetics - For inclusion in the genetic research, subjects must fulfil the following criterion:
    1. Provision of informed consent for genetic research
    E.4Principal exclusion criteria
    1. A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs eg., haematological, gastrointestinal, hepatic or renal disease etc.
    2. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study site).
    3. History of exposure to environmental LPS eg. swine farmers or extensive exposure to passive smoking.
    4. Previous enrolment or randomisation to treatment in the present study.
    5. A definite or suspected personal or family history of intolerance or hypersensitivity to drugs and/or their excipients, judged to be clinically relevant by the investigator.
    6. Surgery or significant trauma within 3 months of Visit 1.
    7. Symptoms, signs or laboratory findings suggestive of an ongoing infective illness at the time of enrolment.
    8. A history of respiratory disease including asthma.
    9. Participation in another study involving an LPS challenge during the past 12 months.
    10. Participation in any clinical study with an investigational drug in the 4 months prior to Visit 1, or participation in a study with a new formulation of a marketed drug in the 3 months prior to Visit 1, or participation in a methodology study in the month prior to Visit 1 (Note: participation is identified as the completion of a treatment-related visit).
    11. Donation of more than 1200 mL of blood within 12 months of Visit 1, or donation of blood in total >500 mL within 3 months prior to Visit 1.
    12. Symptoms of any clinically significant illness within 2 weeks prior to Visit 1.
    13. Use of any prescribed medication in the 3 weeks prior to Visit 1 (other than paracetamol (up to 4 g/day), hormone replacement therapy (HRT) or over-the-counter preparations , herbal preparations or vitamins in the previous 7 days judged to be clinically irrelevant by the Investigator.
    14. Subjects who are pyrexial with a body temperature of greater than 37.7°C .
    15. A significant history of alcohol abuse or consumption of more than 28 units (male) or 21 units (female) of alcohol per week.
    16. A significant history of drug abuse (including benzodiazepines) or positive drugs of abuse test.
    17. Subjects who admit to belonging to a high-risk group for HIV infection according to the site’s standard practice.
    18. Anticipated difficulty with venous access.
    19. Subjects who in the opinion of the investigator should not, for reasons of the safety or compliance, participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome variables are the changes in neutrophil numbers and NE activity in induced sputum following treatment with the active or placebo medication.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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 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 months4
    E.8.9.1In the Member State concerned days
    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 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 state16
    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)
    The participants General Practitioner (GP) will be notified of their involvement in a clinical trial by letter (a Patient Information Sheet will also be sent with the correspondence). On completion or withdrawal from a study the GP will be notified of the participants current medications, changes in health and any adverse events experienced during participation in the trial.
    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 Decision2007-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-21
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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