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    Summary
    EudraCT Number:2009-013929-42
    Sponsor's Protocol Code Number:39588146AHF2001
    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:2009-11-25
    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 number2009-013929-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to
    Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of
    JNJ-39588146 in Subjects with Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number39588146AHF2001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 nameJNJ-39588146 - solution for infusion - 0.2 mg/mL
    D.3.2Product code JNJ-39588146
    D.3.4Pharmaceutical form Solution for 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.3.8INN - Proposed INNnot assigned
    D.3.9.1CAS number not assigned
    D.3.9.2Current sponsor codeJNJ-39588146
    D.3.9.3Other descriptive nameStresscopin Acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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 placeboSolution for 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
    JNJ-39588146 is being developed for the treatment of heart failure.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10019279
    E.1.2Term Heart failure
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the hemodynamic effects, the safety and the tolerability of JNJ-39588146 when administered by intravenous infusion to male subjects and female subjects of non-childbearing potential with New York Heart Association (NYHA) Class II-IV heart failure.
    E.2.2Secondary objectives of the trial
    Characterize the pharmacokinetics of JNJ-39588146 in subjects with heart failure.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Assess the hemodynamics for an 18-hour extended infusion. Assess the effect of JNJ-
    39588146 on relevant cardiovascular biomarkers detected in blood sample.
    E.3Principal inclusion criteria
    1. Subjects must have signed an informed consent document indicating that they
    understand the purpose of the study and the procedures required for the study and are willing to participate in the study.

    2a. Subjects must have systolic dysfunction (LVEF ≤0.35, documented within the
    6 months prior to dosing by any quantitative method) and Heart Failure (New York
    Heart Association [NYHA] functional class II-IV). Subjects considered by the
    principal investigator as having end-stage or refractory heart failure characterized by
    severe cachexia, restriction to bed rest, hospice status or are in imminent need (within the next 30 days) of a left ventricular assist device or heart transplant should not be considered for the study.

    2b. Have a pulmonary capillary wedge pressure ≥20 mm Hg immediately prior to the initiation of the infusion (average of 3 measurements).

    3. Have a cardiac index ≤2.5 L/min/m2 immediately prior to the initiation of the
    infusion (average of 3 measurements).

    4. Subjects must have supine blood pressure (after resting for 5 min) between the range of 95 - 160 mm Hg systolic (inclusive), and 50 - 89 mm Hg diastolic (inclusive) at screening and Day 1 pre-dose.

    5.Criterion modified per amendment
    5.1 Must not have received intravenous heart failure medications including inotropes, vasodilators or diuretics, for at least 18 hours prior to initiation of study infusion. Subjects requiring intravenous medications to control their heart failure (such as inotropes and/or vasodilators within the next 48 hours and/or diuretics within the next 24 hours) should not participate in the study. If there is a planned elective evaluation of a subject’s cardiac response to inotropes/vasodilators, they may participate in the study if the planned elective treatment with these agents is ≥4 hours after the end of the study drug infusion.

    6.Criterion modified per amendment
    6.1 Serum potassium within normal limits confirmed within 2 week of the study drug infusion. If there has been a change in diuretic therapy within these past 2 weeks, serum potassium must be within normal limits within 24 hours of dosing

    7.Criterion modified per amendment
    7.1 Subjects must have a body mass index (BMI) between 18 to 35 kg/m2 (inclusive) and with a minimum body weight of 50 kg.

    8. Female subjects must be of non-childbearing potential, defined as either being:
    - postmenopausal (for at least 24 months) or,
    - surgically sterile for more than 6 months prior to participation in the study
    (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or
    otherwise be incapable of pregnancy), and must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test at screening; and a negative urine pregnancy test on admission to the clinical study unit.

    9. Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and for 3 months after the last dose of study drug and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Medically acceptable methods of contraception that may be used by the subject and/or the partner include double barrier method (condom, diaphragm, or cervical cap used with intravaginal spermicidal foam, cream, or gel), IUD, surgical sterilization (6 months post surgery), post-menopausal partner (not experiencing a menstrual period for a minimum of two years) and hormonal contraceptives (which must be used consistently for 3 months prior to the initiation of the study drug infusion) such as oral contraceptives, hormonal patches, progestin implants or injections, and etonogestrel/ethinyl estradiol vaginal rings (NuvaRing®).

    10.Criterion modified per amendment
    10.1 Male or female subjects between 18 and 86 years of age, inclusive.

    11. Willing/able to adhere to the prohibitions and restrictions specified in this protocol.
    E.4Principal exclusion criteria
    1. Subjects without bundle branch block with confirmed screening QTcF interval >450
    msec in males or > 470 msec in females. Subjects with bundle branch block or
    receiving amiodarone with confirmed screening QTcF interval >500 msec. Subjects
    with a history of additional risk factors for torsades de pointe (eg, hypokalemia, family history of Long QT Syndrome), or the use of concomitant medications that
    prolong the QT/QTc interval.

    2. Subjects with atrial fibrillation, sinus tachycardia, sustained ventricular tachycardia,
    ventricular fibrillation within the last 30 days or third degree heart block at screening
    or check-in.

    3. Subjects with a resting heart rate less than 50 or greater than 100 beats per minute (via ECG output pre-dose).

    4.Criterion modified per amendment
    4.1 Acute coronary syndrome, myocardial infarction or coronary revascularization (CABG or percutaneous coronary intervention) within 1 month or history of resuscitated sudden death or systemic shock.

    5. Subjects with a left-ventricular assist device or heart transplant or mechanical
    ventilation.

    6. Subjects with hemodynamically-significant primary valvular heart disease.

    7. Subjects with serum digoxin concentrations (minimum levels) >1.5 ng/ml at
    screening.

    8. Subjects in whom the PA catheter is being placed solely for study measurements,
    with an INR >1.5 when femoral, subclavian or jugular approach is used.

    9. History of transient ischemic attack within the 6 months before screening.

    10. History of clinically significant chronic hepatic, reproductive, gastrointestinal,
    primary renal, hematologic, pulmonary, neurologic, respiratory or psychiatric
    disorders, and oncologic conditions or acute or chronic infection.

    11. Subjects with uncontrolled hypertension or/and uncontrolled diabetes.

    12.Criterion modified per amendment
    12.1 Subjects with ALT or AST greater than 3 times the upper limit of normal at screening may not participate in the study.


    13. Subjects with creatinine clearance <30 mL/min at screening or subjects requiring
    dialysis or serum ultra-filtration.

    14. Any condition that, in the opinion of the Investigator, would compromise the well
    being of the subject or the study or prevent the subject from meeting or performing
    study requirements.

    15. Subjects for which there is a concern of right intra-ventricular lead displacement
    including subjects who have had placement of pacemaker or ICD within the past
    3 months before screening.

    16. Subjects with heart failure caused by myositis, lung disease, congenital heart disease, constrictive pericarditis, or hypertrophic or restrictive cardiomyopathy.

    17. Subjects planning to parent a child during the study or within 3 months after the last dose of study drug.

    18. Pregnant or breast-feeding females.

    19. Employees of the Investigator or study center, with direct involvement in the
    proposed study or other studies under the direction of that Investigator or study
    center, as well as family members of the employees or the Investigator.

    20. Known allergies, hypersensitivity, or intolerance to JNJ-39588146 or its excipients
    (refer to Section 14.1, Physical Description of Study Drug(s)), or urocortin or
    urocortin 2.

    21. Received an investigational drug (including vaccines) or used an investigational
    medical device within 30 days before the planned start of treatment, or within a
    period of less than ten times the drug’s half-life, whichever is longer.

    22. Subjects who have donated blood or plasma, or have had blood loss of more than 500 mL within 8 weeks prior to check-in, or plan to donate blood or plasma during the study.

    23. Subjects with drug or alcohol abuse within the past 2 months prior to dosing or at risk of withdrawal symptoms during the study.
    E.5 End points
    E.5.1Primary end point(s)
    Two primary endpoints are the post-baseline changes (at 1-hour, 2 hours and 3 hours post infusion initiation) in pulmonary capillary wedge pressure and cardiac index. The two primary endpoints will be used separately to compare JNJ-39588146 with placebo.
    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 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 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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
    provided in the protocol
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 60
    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 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 Decision2010-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-05
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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