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    Summary
    EudraCT Number:2008-000724-12
    Sponsor's Protocol Code Number:D0520C00002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-04
    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 ConcernedGermany - BfArM
    A.2EudraCT number2008-000724-12
    A.3Full title of the trial
    A 2-week, randomised, double-blind, placebo-controlled, parallel group study to assess the tolerability and pharmacokinetics of orally administered AZD9668 in patients with COPD
    A.4.1Sponsor's protocol code numberD0520C00002
    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
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    1. To investigate the tolerability of 14 days’ dosing with AZD9668 in patients with COPD, as measured by vital signs, ECG, lung function, haematology, clinical chemistry, urinalysis and adverse event reporting.

    2. To determine the plasma pharmacokinetics and renal clearance of AZD9668 in patients with COPD.
    E.2.2Secondary objectives of the trial
    1. To assess the effect of orally administered AZD9668 on neutrophils in induced sputum of patients with COPD.

    2. To investigate the effects of AZD9668 on sputum bacteriology.

    3. To measure the concentration of AZD9668 in induced sputum following oral administration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be willing and able to comply with study procedures and provide written informed consent

    2. Be male or post-menopausal (for more than 12 months)/surgically sterile female between 40 and 80 years

    3. Have a clinical diagnosis of COPD

    4. Smokers or ex-smokers (with at least 10 pack years)

    5. Post-bronchodilator FEV1 30 - 80% predicted, FEV1/FVC ratio < 70%
    (GOLD stage II to III, GOLD 2007)


    For inclusion in this genetic research, patients must fulfil the following criterion:
    1. Provision of informed consent for genetic research
    E.4Principal exclusion criteria
    1. Concomitant diagnosis of significant pulmonary disease other than COPD, including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary aspergillosis

    2. An acute exacerbation (defined as an increase in respiratory symptoms requiring hospitalisation and/or a course of oral glucocorticosteroids and/or antibiotics, either prescribed or self administered); or acute respiratory infection (upper or lower) in the 4 weeks prior to Visit 1 or Visit 2

    3. Use of oral corticosteroids in the 8 weeks prior to Visit 2 (use of inhaled corticosteroids is allowed)

    4. Use of antibiotics, systemically or nebulised, in the 4 weeks prior to Visit 1 or Visit 2

    5. Current requirement for oxygen therapy

    6. Any other clinical disease or disorder (including insulin-dependent diabetes) which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study

    7. Positive test result for HIV, Hepatitis B or C

    8. Scheduled in-patient surgery or hospitalisation during the course of the study

    9. Previous randomisation into the present study

    10. Participation in another clinical study involving an investigational product within 4 weeks or 5 times the half life, whichever is longer, of Visit 1

    11. A past history of or current clinical or laboratory evidence of renal disease, or a calculated creatinine clearance (Cockcroft-Gault formula) of ≤70 ml/min at Visit 1

    12.
    (a) QTc >450 ms for males and >470 ms for females in the screening ECG

    (b) The presence of any arrhythmia in the ECG at Visit 1. which in the opinion of the investigator may put the patient at risk or interfere with study assessments. (Premature ventricular or supraventricular ectopics up to 6/minute will be allowed at the investigators discretion, as long as there are no other associated cardiac abnormalities)

    (c) Current or previous history of coronary artery disease, or congestive cardiac failure or any other clinically significant cardiac disease

    13. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at Visit 1, which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.

    14. Patients who, in the opinion of the investigator, should not participate in the study.

    15. History of excessive alcohol consumption or chronic alcohol induced disease. Excessive alcohol consumption will be defined as the consumption >28 units/week in males or >21 units in females [1 unit is equivalent to half a pint (285 ml) of beer, 1 glass (125 ml) of wine or 1 measure (25 ml) of spirits].

    16. If participation in the study would result in the volunteer donating more than 1350 mL of blood in the 12 months or 500 mL of blood in the 3 months before the end of the study

    17. The patient is not able to understand and comply with protocol requirements, instructions and protocol-stated restriction

    18. Vulnerable patients (e.g. persons kept in detention).

    19. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
    E.5 End points
    E.5.1Primary end point(s)
    Tolerability:
    Adverse events, vital signs, ECG, lung functions, haematology, clinical chemistry, and urinalysis.

    Pharmacokinetic:
    AZD9668 plasma and urine concentrations
    Day 1: Cmax, tmax, AUC(0-t), AUC(0-24), C24, AUC, t1/2, CL/F, Vz/F, CLR, Ae and Fe (%)
    Day 7: Cmin,ss
    Day 14: Cmin,ss, C,max,ss, tmax, AUC(0-t),ss, AUC(0-24),ss, C24,ss, AUCss, t1/2ss, CL/Fss, Vz/Fss, Rac, CLR, Ae,ss and Fe,ss (%)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    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 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.8.6 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
    The end of the trial is defined as the date of database lock
    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 months5
    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 months5
    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) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 18
    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)
    Each patient’s continued treatment after completion of trial will be chosen at the discretion of the investigator, and according to local clinical practice.
    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 Decision2008-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-29
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