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    Summary
    EudraCT Number:2006-001871-39
    Sponsor's Protocol Code Number:CY 1121
    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:2006-10-09
    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 number2006-001871-39
    A.3Full title of the trial
    A PHASE II, MULTI CENTRE, DOUBLE-BLIND, RANDOMISED, PLACEBO CONTROLLED, DOSE-ESCALATION, PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF CK-1827452 IN PATIENTS WITH STABLE HEART FAILURE.
    A.4.1Sponsor's protocol code numberCY 1121
    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 SponsorCytokinetics, Inc
    B.1.3.4CountryUnited States
    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 nameCK-1827452
    D.3.2Product code CK-1827452
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCY 1121
    D.3.9.3Other descriptive nameCK-1827452
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboIntravenous infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The drug is being developed for heart failure. This is the first study in patients with stable heart failure .
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Objective:

    •To evaluate the safety and tolerability of CK-1827452 Injection administered as an intravenous infusion to stable heart failure patients.
    E.2.2Secondary objectives of the trial
    •To establish a relationship between plasma concentration and pharmacodynamic effect for CK 1827452 Injection.

    •To determine the pharmacokinetics of CK-1827452 Injection in stable heart failure patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient is male, or female of non-childbearing potential (two years post-menopausal or surgically sterilised)
    2.Female patients must have a negative urine pregnancy test prior to entry into the study
    3.Patient is 18 years old or greater
    4.Patient has given signed informed consent
    5.Patient is considered to be in suitable health in the opinion of the investigator, as determined by:
    - A pre-study physical examination with no clinical abnormalities which in the opinion of the investigator would preclude participation in the study other than physical symptoms or signs consistent with stable heart failure
    - An ECG with no abnormalities in the opinion of the investigator that would impair assessment of stopping criteria
    6.Patient has pre-study clinical laboratory findings that are within normal range, or if outside of the normal range, should not preclude participation in the study in the opinion of the investigator (see Exclusion Criteria, below, for exceptions)
    7.Patient has a documented diagnosis of heart failure with an ejection fraction of less than 40%, except for Cohort 4, where ejection fraction must be less than or equal to 30%
    8.Patient has been on a stable dose of a beta blocker and an ACE inhibitor (or an ARB) for at least 4 weeks. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks.
    9.Patient is currently in sinus rhythm
    10.Patient has interpretable echocardiographic images on a screening echocardiogram
    E.4Principal exclusion criteria
    1. Patient has been hospitalised for heart failure, myocardial infarction, coronary
    revascularisation, or another cardiac indication within the last 6 weeks
    2. Patient has a current history of alcohol use which in the opinion of the investigator would preclude participation in the study
    3. Patient has a current history of drug abuse
    4. Patient has donated blood or blood products within 30 days prior to screening
    5. Patient has CCS Class III or IV angina
    6. Patient has significant obstructive valvular disease or significant congenital heart
    disease
    7. Patient has had a valve replacement
    8. Patient is pacemaker dependent
    9. Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
    10. Patient is currently taking, or has taken in the last 7 days, a CYP3A4 inhibitor or inducer
    medication listed in Appendix C
    11. Patient has a history of hypertrophic obstructive cardiomyopathy
    12. Patient weighs > 120 kg
    13. Patient has a supine resting systolic blood pressure < 95 mmHg after 3 minutes rest
    14. Patient has a supine resting systolic blood pressure > 160 mmHg after 3 minutes rest
    15. Patient has a supine resting diastolic blood pressure > 100 mmHg after 3 minutes rest
    16. Patient has a supine resting heart rate ≥ 100 beats per minute after 3 minutes rest
    17. Patient has an Modification of Diet in Renal Disease (MDRD) estimate of
    GFR ≤ 35 ml/min/1.73 m2 (see Appendix D)
    18. Patient has a potassium < 3.5 mEq/L or > 5.5 mEq/L
    19. Patient has a sodium ≤ 133 mEq/L
    20. Patient has a urea > 15 mmole/L
    21. Patient has a troponin I or T at screening that is detectable at the investigative site’s clinical laboratory
    22. Patient has a haemoglobin < 11 gm/dL in males or < 10 gm/dL in females
    23. Patient has an ALT, AST, ALKP or TBILI > 3 times the upper limit of normal
    24. Patient is, in the opinion of the investigator, not suitable to participate in the study
    25. Patient has participated in any clinical study with an investigational drug within three months prior to the first day of dosing with the exception of coronary stent studies
    26. Patient has ever received CK-1827452
    E.5 End points
    E.5.1Primary end point(s)
    To determine the pharmacokinetics of CK-1827452 injection in stable heart failure patients.
    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 Information not present in EudraCT
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    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 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 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 study is defined as the last scheduled protocol activity of the last patient in the study. Follow-up visits for adverse events ongoing at the last scheduled study activity or for repeat laboratory assessments are considered to be part of the patient’s ongoing medical care and not study assessments.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 No
    F.3.2Patients Yes
    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 state32
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 56
    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 Decision2006-11-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-02-12
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