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    Summary
    EudraCT Number:2010-021642-22
    Sponsor's Protocol Code Number:VR1114693
    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:2010-12-30
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-021642-22
    A.3Full title of the trial
    A two part study to investigate the pharmacokinetics and pharmacodynamics of SB705498, a TRPV1 antagonist, in cough. Part A: an open label study in healthy subjects to determine the exposure to SB-705498. Part B: a randomized, double-blind, placebo controlled, cross over study to investigate the effects of SB-705498 on capsaicin-induced cough and 24 hour cough counts in patients with chronic cough.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Two part study investigating the effects of SB-705498 in chronic cough
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberVR1114693
    A.7Trial is part of a Paediatric Investigation Plan No
    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 supportGlaxoSmithKline Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClincial Trails Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road, Stockley Park West
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 - 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44208990 44 66
    B.5.5Fax number+44208990 12 34
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    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 nameSB-705498
    D.3.2Product code SB-705498
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 codeSB-705498
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 cough
    E.1.1.1Medical condition in easily understood language
    Chronic cough
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A:
    To determine the systemic exposure following a single oral dose of 400mg SB-705498 (4 x 100mg tablets).
    To determine the capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo.

    Part B:
    To determine the capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo.
    To assess the effect of SB-705498 or placebo on 24 hour ambulatory cough counts.
    E.2.2Secondary objectives of the trial
    Part A:
    To determine the capsaicin concentration required to achieve C2 following a single dose of SB-705498.
    To assess the safety tolerability of a single oral dose of SB-705498.

    Part B:
    To assess the effect of SB-705498 or placebo on the Cough Specific Quality of Life
    questionnaire (CQLQ).
    To determine the capsaicin concentration required to achieve C2 following a single dose of SB-705498 or placebo.
    To assess the effect of SB-705498 or placebo on the urge to cough, following capsaicin challenge over a 24 hour period post dose.
    To determine the capsaicin concentration required to achieve C5, 24h post-dose, following a single dose of SB-705498 or placebo.
    To determine the capsaicin concentration required to achieve C2, 24 h post-dose, following a single dose of SB-705498 or placebo.
    To assess the safety tolerability of a single oral dose of SB-705498 .
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 and laboratory tests, with the exception of chronic cough (chronic cough applies to Part B only). 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.
    3. Part B only: Idiopathic or chronic cough resistant to treatment targeted at potential triggers.
    4. Male or female between 30 -75 (part A), and 18 - 75 (part B) years of age inclusive, at the time of signing the informed consent.
    5. A female subject is eligible to participate if she:
    • Is of non-childbearing potential defined as females with a documented 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 (<147 pmol/L) 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 postmenopausal 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 postmenopausal
    status, they can resume use of HRT during the study without use of a
    contraceptive method.
    • Is of 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 84 days post-last dose.
    • Has undergone tubal ligation and agrees to perform a pregnancy test at time points specified in the Time and Events Table, Section 4.6.
    6. Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 84 days post-last dose.
    7. Non-smoker for at least 6 months with a pack history ≤5pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
    8. Body weight ≥ 50 kg and BMI within the range 19 – 32.0 kg/m2 (inclusive).
    9. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    10. Single QTcB < 450 msec; or QTcB < 480 msec in subjects with Bundle Branch Block.
    E.4Principal exclusion criteria
    1. History of a positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening or at screening.
    2. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    3. History of confirmed positive pre-study drug/alcohol screen.
    4. Part A only: Positive test for HIV antibody.
    5. History of regular alcohol consumption within 6 months of the study defined as:
    • An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
    6. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
    7. Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
    8. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
    9. Known lung cancer or other active malignancy, or history of.
    10. Current treatment with oral corticosteroids or other immunosuppressive agents.
    11. FEV1 less than 80% of the predicted value prior to dosing.
    12. Any subject who does not reach C5 following an oral inhalation challenge of capsaicin at a dose level of 250 μM.
    13. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
    14. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
    15. Pregnant females as determined by positive hCG test at screening or prior to dosing.
    16. Lactating females.
    17. Unwillingness or inability to follow the procedures outlined in the protocol.
    18. Subject is mentally or legally incapacitated.
    19. Cotinine levels indicative of smoking or history 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 from 7 days prior to the first dose of study medication.
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    PK exposure following 10 hour sampling of a single dose of SB-705498.Capsaicin
    concentration required to achieve C5 following a single dose of SB-705498 at Tmax as compared to baseline.

    Part B:
    To determine the capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo.
    24 hour cough count following single dose of SB-705498 as compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    PK sampling will be performed at various intervals over the course of Day 1.

    Part B:
    Capsaicin challenge will be performed at 2 hours following dosing with study drug on Day 1 of both treatment periods.
    Cough count will be monitored continuously from prior to dosing with study drug until 24 hours after dosing on Day 1 of each treatment period.

    E.5.2Secondary end point(s)
    - Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at Tmax as compared to baseline.
    - Safety parameters: AEs, vital signs, ECG, body temperature and laboratory assessments, including haematology and clinical biochemistry.
    - Changes in the CQLQ following a single dose of SB-705498 compared to placebo.
    - Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at Tmax as compared to baseline.
    - Urge to cough VAS following single dose of SB-705498.
    - Capsaicin concentration required to achieve C5 following a single dose of SB-705498 at
    - 24 hours as compared to baseline.
    - Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at 24 hours as compared to baseline.
    - Safety parameters: AEs, vital signs, ECG, body temperature and laboratory assessments, including haematology and clinical biochemistry.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The intervals of endpoint measurement vary throughout the study, by endpoint (as is normal for a clinical study) relative to when dosing with study drug occurs. Intervals range from a 30minute basis on each day of
    dosing, up to 14 days post last dose in each treatment period.
    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 No
    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 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.8.5.1Number of sites anticipated in the EEA1
    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 No
    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
    LSLV
    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 months8
    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 months8
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 42
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 42
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 42
    F.4.2.2In the whole clinical trial 42
    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 from GSK after completion of the study because the indication being studied is not life threatening.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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