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    Summary
    EudraCT Number:2010-020157-13
    Sponsor's Protocol Code Number:HZA111789
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-07-07
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-020157-13
    A.3Full title of the trial
    An open-label, non-randomized, pharmacokinetic and safety study of repeat doses of fluticasone furoate and GW642444M combination in healthy subjects and in subjects with mild, moderate or severe hepatic impairment
    A.4.1Sponsor's protocol code numberHZA111789
    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 SponsorGlaxoSmithKline Research & Development 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 nameFluticasone Furoate/GW642444 Inhalation Powder
    D.3.2Product code Fluticasone Furoate/GW642444 Inhalation Powder
    D.3.4Pharmaceutical form Inhalation powder, pre-dispensed
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGW685698 (Fluticasone furoate)
    D.3.9.1CAS number 397864-44-7
    D.3.9.2Current sponsor codeGW685698X
    D.3.9.3Other descriptive nameFLUTICASONE FUROATE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGW642444M
    D.3.9.1CAS number 503070-58-4
    D.3.9.2Current sponsor codeGW642444
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    healthy subjects and in subjects with mild, moderate or severe hepatic impairment
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10052254
    E.1.2Term Hepatic impairment
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of varying degrees of hepatic impairment on the pharmacokinetics of FF and GW642444 following repeat administration of FF 200mcg/GW642444M 25mcg via a novel Dry Powder Inhaler (NDPI).
    E.2.2Secondary objectives of the trial
    •To investigate the effect of varying degrees of hepatic impairment on serum cortisol
    suppression following repeat administration of FF 200mcg/GW642444M 25mcg via
    a NDPI.
    • To investigate the effect of varying degrees of hepatic impairment on heart rate
    following repeat administration of FF 200mcg/GW642444M 25mcg via a NDPI.
    • To investigate the effect of varying degrees of hepatic impairment on serum
    potassium following repeat administration of FF 200mcg/GW642444M 25mcg via a
    NDPI.
    • To investigate the effect of varying degrees of hepatic impairment on safety and
    tolerability following repeat administration of FF 200mcg/GW642444M 25mcg via a
    NDPI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female between 18 and 70 years of age inclusive, at the time of signing the informed consent.
    2. A female subject is eligible to participate if she is of:
    • Non-childbearing potential defined as pre-menopausal females with a
    documented tubal ligation or hysterectomy; or postmenopausal defined as 12
    months of spontaneous amenorrhea [in questionable cases a blood sample with
    simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol <
    40 pg/ml (<140 pmol/L) (healthy subjects only) is confirmatory]. Females on
    hormone replacement therapy (HRT) and whose menopausal status is in doubt
    will be required to use one of the contraception methods in Section 8.1 if they
    wish to continue their HRT during the study. Otherwise, they must discontinue
    HRT to allow confirmation of post-menopausal status prior to study enrollment.
    For most forms of HRT, at least 2-4 weeks will elapse between the cessation of
    therapy and the blood draw; this interval depends on the type and dosage of
    HRT. Following confirmation of their post-menopausal status, they can resume
    use of HRT during the study without use of a contraceptive method.
    • Child-bearing potential and agrees to use one of the contraception methods
    listed in Section 8.1 for an appropriate period of time (as determined by the
    product label or investigator) prior to the start of dosing to sufficiently minimize
    the risk of pregnancy at that point. Female subjects must agree to use
    contraception until completion of the follow-up visit.
    3. BMI within the range 19 – 33 kg/m2.
    4. Able to satisfactorily use the dry powder inhalation inhaler.
    5. Capable of giving written informed consent, which includes compliance with the
    requirements and restrictions listed in the consent form.
    6. Single QTcF < 450 msec; or QTcF < 480 msec in subjects with Bundle Branch
    Block.
    Healthy subjects
    1. AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin
    >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
    2. Healthy as determined by a responsible and experienced physician, based on a
    medical evaluation including medical history, physical examination, laboratory tests
    and cardiac monitoring. A subject with a clinical abnormality or laboratory
    parameters outside the reference range for the population being studied may be
    included only if the Investigator and the GSK Medical Monitor agree that the finding
    is unlikely to introduce additional risk factors and will not interfere with the study
    procedures or outcome.
    Hepatically Impaired Subjects
    1. Hepatically impaired.
    To be classified as hepatically impaired, subjects must have:
    Known medical history of liver disease with or without a known history of alcohol
    abuse; and A Child-Pugh score of 5-15 to cover all severities (Mild = 5-6 points; Moderate = 7-
    9 points; Severe = 10-15 points). The components that contribute to the CP score
    should be directly related to the underlying hepatic disease and not to non-hepatic
    disease.
    2. Subjects with no significant abnormality, apart from impaired hepatic function and
    related symptoms, or clinical examination. A subject with a clinical abnormality
    may be included only if the Investigator considers that the abnormality will not
    introduce additional risk factors and will not interfere with the study procedures.
    Hepatically impaired subjects with other laboratory parameters outside the reference
    ranges will only be included if, in the opinion of the Investigator, the result is not
    clinically important and introduces no additional risk factors.
    E.4Principal exclusion criteria
    1. Suffered a lower respiratory tract infection in the 4 weeks before the screening visit.
    2. Taken oral corticosteroids less than 8 weeks before the screening visit.
    3. Taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
    4. Have a known sensitivity to corticosteroids and/or long acting beta agonists.
    5. A positive pre-study drug/alcohol screen.
    6. A positive test for HIV antibody.
    7. The subject has participated in a clinical trial and has received an investigational product view page 26 of the protocol for further information.
    8. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    9. History of sensitivity to any of the study medications, or components view page 26 of the protocol for further information.
    10. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    11. Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
    12. Lactating females.
    13. The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
    14. Unwillingness or inability to follow the procedures outlined in the protocol.
    15. Subject is mentally or legally incapacitated.
    16. History of sensitivity to heparin or heparin-induced thrombocytopenia.
    17. Subjects who have asthma or a history of asthma.
    18. History of severe milk protein allergy.
    19. Subjects with a smoking history of >10 cigarettes per day or regular use of tobacco or nicotine-containing products, within 6 months prior to screening.
    20. Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
    Healthy subjects
    1. If, in the opinion of the examining physician, an unstable cardiovascular, renal, hepatic condition, view page 26 of the protocol for further information.
    2. Subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism or excretion of drugs or any previous gastrointestinal (GI) surgery (view page 27 of the protocol for further information.
    3. Haemoglobin values <12.9g/dL for males and <11.4g/dL for females.
    4. A past history or current symptoms of significant hepatic or renal disease, pancreatitis or acute cholecystitis view page 27 of the protocol for further information.
    5. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
    6. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    7. History of regular alcohol consumption within 6 months of the study defined as: View page 26 of the protocol.
    8. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements view page 27 of the protocol for further information.
    1. If in the opinion of the examining physician, an unstable cardiovascular, renal, pulmonary condition, view page 26 of the protocol for further information.
    2. Severe ascities (Child-Pugh ascites score of 3) upon clinical exam, including physical exam and abdominal ultrasound at screening. View page 26 of the protocol page for further information.
    3. History of oesophageal bleeding within the last 6 months before dosing.
    4. Significant hepatic encephalopathy, degree of CNS impairment or other signs of hepatic function deterioration view page 27 of the protocol for further information.
    5. Patients at risk of requiring a transfusion during the study period, or has haemoglobin < 9 g/dL - view page 27 of the protocol for further information.
    6. Evidence of current significant infection (e.g. spontaneous bacterial peritonitis, pneumonia etc.).
    7. Subjects who develop symptoms such as infections or haemorrhage between screening and dosing must not be included in the study.
    8. Fluctuating or rapidly deteriorating hepatic function - view page 27 of the protocol for further information.
    9. Subjects with significant renal insufficiency as defined by estimated creatinine clearance of <50 ml/min, using the Cockcroft and Gault equation.
    10. Subjects with a diagnosis of primary biliary disease such as cholestasis or sclerosing cholangitis.
    11. Subjects who need to take any concomitant medication, either prescribed or over-the counter, which may in the opinion of the Investigator, interfere in any way with the study procedure or be a safety concern view page 27 of the protocol for further information.
    12. Subjects who, within the past six months, have had a history of significant drug abuse or alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    • Fluticasone furoate and GW642444 pharmacokinetics (AUC(0-t), AUC (0-8), Cmax,
    tmax) on Day 1 and 7 and AUC(0-24) and t½ on Day 7.
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 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
    Last Subject Last visit
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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)
    Subjects will not receive any additional treatment after completion of the study because the subjects recruited into this study do not have COPD or asthma.
    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 Decision2010-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-15
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