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    Summary
    EudraCT Number:2009-010615-32
    Sponsor's Protocol Code Number:PM1111810
    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:2009-10-22
    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 number2009-010615-32
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the safety of 12 weeks of dosing with GW856553 and its effects on inflammatory markers, infarct size, and cardiac function in subjects with myocardial infarction without STsegment
    elevation
    A.3.2Name or abbreviated title of the trial where available
    SOLSTICE
    A.4.1Sponsor's protocol code numberPM1111810
    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 R&D 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 nameGW856553
    D.3.2Product code GW856553
    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 INNLosmapimod
    D.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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 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 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
    Subjects with myocardial infarction without ST-segment elevation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064347
    E.1.2Term Non ST segment elevation myocardial infarction
    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 assess the safety of GW856553 in subjects with NSTEMI.
    2. To assess the effects of GW856553 on biomarkers of inflammation in subjects with NSTEMI over the 12 weeks of treatment.
    3. To assess the effects of GW856553 on infarct size and cardiac function during the peri-infarct period and during the ensuing 12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Various exploratory endpoints, including coronary pressure/flow, PK/PD and quality of life will be evaluated.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There are two sub-studies; Cardian MRI Substudy and Coronary Flow and pressure Sub-study. These are described within the main protocol for PM1111810 and therefore do not have a separate date and version number.
    The purpose of the MRI Substudy is to determine myocardial infarct size by delayed enhancement MRI.
    The rationale for the Coronary Flow and pressure sub-study is that coronary flow reserve and fractional flow reserve are strong predictors of coronary event rates.
    E.3Principal inclusion criteria
    1. Subjects with a NSTEMI, defined as:
    • symptoms (e.g. chest pain, dyspnea) consistent with acute coronary syndrome, lasting at least 10 minutes, and occurring within the 24 hours prior to presentation,
    • without persistent ST-segment elevation on admission 12-lead ECG, and
    • with Troponin (T or I) above the upper limit of normal (ULN) for the local institution within 18 hours of presentation.
    2. Subject able to be randomized within 12 hours of presentation.
    3. Subjects likely to be managed with an early invasive strategy, with PCI likely to
    occur at least 2 hours after the start of dosing.[subjects who do not undergo PCI
    will not be withdrawn from study].
    4. Male or female subject who is 45 years of age or older.
    5. 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) is confirmatory), or
    • Child-bearing potential and agrees to use one of the contraception methods listed in Section 7.1.1 of the protocol for the duration of dosing and until the first follow-up visit (~2 weeks post last-dose).
    6. Negative urine or serum pregnancy test (in women of child-bearing potential only).
    7. Male subjects must agree to use one of the contraception methods listed in Section 7.1.2 of the protocol. This criterion must be followed from the time of the first dose of study medication until the first follow-up visit (~2 weeks post last-dose).
    8. QTcB or QTcF </= 530 msec.
    9. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    E.4Principal exclusion criteria
    1. History of severe heart failure defined as NYHA class III or IV or those with known severe LV dysfunction [ejection fraction (EF) < 30%] regardless of symptomatic status.
    2. Suspected aortic dissection.
    3. Severe aortic stenosis or other severe valvular disease.
    4. Current known life-threatening condition other than vascular disease (e.g. severe chronic airways disease) that may prevent a subject from completing the study.
    5. Subjects with rheumatoid arthritis, connective tissue disorders and other conditions
    known to be associated with active chronic or acute inflammation (e.g. inflammatory
    bowel disease, osteomyelitis, pneumonia, sepsis, etc.). Intermittent conditions
    treated with short-term oral antibiotics (e.g. typical URI), or conditions that are
    not currently exacerbated (e.g. gout with no current flair) may be included.
    6. History of myopathy or rhabdomyolysis.
    7. Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
    8. Known to be Hepatitis B or Hepatitis C positive.
    9. Current or anticipated use of systemic steroids (oral or IV). Inhaled, intranasal
    and topical steroids are allowed. A single prophylactic dose of systemic steroid
    is allowed at time of PCI for subjects with contrast allergy.
    10. Current or anticipated use of BCRP substrates with a narrow therapeutic index (e.g. daunorubicin, doxorubicin, topotecan, mitoxantrone);
    Previously diagnosed cancer that has not been in complete remission for at least
    5 years. Localized carcinomas of the skin and carcinoma in situ of the cervix
    that have been resected or ablated for cure are not exclusionary.11.
    12. Known alcohol or drug abuse within the past 6 months.
    13. Previous exposure to GW856553.
    14. Use of another investigational product within 30 days or 5 half-lives (whichever is the longer) preceding the first dose of IP in the current study.
    15. Any other subject whom the Investigator deems unsuitable for the study (e.g., due to either medical reasons, laboratory abnormalities, expected study medication noncompliance).
    16. Unwillingness or inability to follow the procedures outlined in the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    • A safety evaluation will be made by assessment of all adverse events, major adverse cardiovascular events (MACE) as defined in Section 11.3, safety laboratory tests (including liver function values), vital signs and 12-lead ECG parameter

    Inflammatory Endpoints
    •hsCRP at Week 12

    Myocardial Infarct Sizeand Cardiac Function Endpoints
    •cTnI AUC over 72 hours post-randomization or until hospital discharge (whichever comes first).
    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 Yes
    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 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    As stated in Section 9.4 of the protocol;

    There will be no treatment with GW856553 after the end of the study. Subjects enrolled into this study will already be receiving the appropriate standard of care, and this care will be continued at the end of the study (as per the subject's local physician).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 400
    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)
    Please see section 9.4 of protocol
    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 Decision2009-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
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