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    Summary
    EudraCT Number:2020-006131-10
    Sponsor's Protocol Code Number:APD418-201
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-006131-10
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Hemodynamic Effects, Safety, Tolerability, and Pharmacokinetics of APD418 in Subjects with Heart Failure with Reduced Ejection Fraction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess how Safe and Effective APD418 is in Patients with Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    APD418-201
    A.4.1Sponsor's protocol code numberAPD418-201
    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 SponsorArena Pharmaceuticals, 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 supportArena Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationArena Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointMehreen Hai
    B.5.3 Address:
    B.5.3.1Street Address6154 Nancy Ridge Drive
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92121
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18582103639
    B.5.6E-mailct.gov@arenapharm.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 nameAPD418
    D.3.2Product code APD418
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 applicable
    D.3.9.1CAS number 2169905-68-2
    D.3.9.2Current sponsor codeAPD418, APD418 mesylate hemihydrate, AR504330
    D.3.9.3Other descriptive nameAPD418 mesylate hemihydrate
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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
    Treatment of acute heart failure with reduced ejection fraction (HFrEF)
    E.1.1.1Medical condition in easily understood language
    Treatment of acute heart failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the effect of intravenous (IV) infusion of APD418 on hemodynamic status based on cardiac index (CI) in subjects with heart failure with reduced ejection fraction (HFrEF)
    E.2.2Secondary objectives of the trial
    • To assess the effect of IV infusion of APD418 on additional hemodynamic, vital sign, and systolic function parameters in subjects with HFrEF
    • To assess the pharmacokinetics (PK) of IV infusion of APD418 in subjects with HFrEF
    • To assess the safety and tolerability of IV infusion of APD418 in subjects with HFrEF
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Optional pharmacogenetic (DNA research) sub-study, v 1.0, dated 09 March 2021
    Objective: In addition to analyses performed during the study, samples will be saved for potential future exploratory research aimed at identifying/exploring genetic variations and response to APD418 that may affect its pharmacokinetics (PK), pharmacodynamics, safety, or tolerability, if warranted.

    2. Pregnancy Follow-up, v 1.0, dated 09 March 2021
    Objective: Assessment if there is any risk to the study participant or study participant's partner or unborn baby. Followed up to delivery (or outcome) and through to the first well-baby visit (if applicable).
    E.3Principal inclusion criteria
    • Advanced chronic Heart Failure with Reduced Ejection Fraction (HFrEF), defined as left ventricular ejection fraction (LVEF) ≤ 35% at Screening, including documented history of HFrEF (LVEF ≤ 35%) for at least 4 months prior to Screening
    • New York Heart Association Class II-IV
    • Cardiac index ≤ 2.5 liters per minute per square meter (L/min/m^2) and pulmonary capillary wedge pressure ≥ 15 millimeters of mercury (mm Hg) at Day 1
    • Body mass index 18.0 to 37.0 kilograms per square meter (kg/m^2),
    inclusive
    E.4Principal exclusion criteria
    • Hemodynamically unstable at Day 1 or in the opinion of the Investigator likely to progress to being hemodynamically unstable during the course of the study
    • Treated with dobutamine, dopamine, or milrinone within 7 days of Day 1 or with levosimendan within 21 days of Day 1, or expected to require therapy with these drugs any time from Day 1 through the end of study conduct
    • Treated with vasoactive or intravenous (IV) diuretic therapy within 24 hours of Day 1, or expected to require IV therapy any time from Day 1 through the end of the in-clinic observation Postdose Period
    E.5 End points
    E.5.1Primary end point(s)
    Change in CI measured by RHC from Baseline to end of IV infusion at 6 hours
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to end of intravenous (IV) infusion at 6 hours
    E.5.2Secondary end point(s)
    Secondary endpoints:
    • Change in the following hemodynamic parameters measured by RHC from Baseline to end of IV infusion at 6 hours:
    − Cardiac output (CO)
    − Pulmonary capillary wedge pressure (PCWP)
    − Right atrial pressure (RAP)
    − Systolic/diastolic pulmonary arterial pressure (PAS/PAD)
    − Pulmonary artery pulsatility index (PAPi)
    − Systemic vascular resistance/systemic vascular resistance index (SVR/SVRI)
    − Pulmonary vascular resistance (PVR)
    • Change in the following vital sign parameters from Baseline to end of IV infusion at 6 hours:
    − Systolic blood pressure (SBP)
    − Diastolic blood pressure (DBP)
    − Mean arterial pressure (MAP)
    − Heart rate (HR)
    • Change in the following hemodynamic and systolic function parameters measured by echocardiogram (ECHO) from Baseline to end of IV infusion at 6 hours:
    − Stroke volume (SV)
    − SV index (SVI)
    − Left ventricular ejection fraction (LVEF)
    − Fractional shortening (FS)
    − Left ventricular end systolic/left ventricular end-diastolic volume (LVESV/LVEDV) and diameter
    − Left ventricular global longitudinal strain (LVGLS)
    − Left ventricular circumferential strain (LVGCS)
    • Change in hemodynamic (measured by RHC) and vital sign parameters listed above at intermediate timepoints during 6-hour IV infusion (during Dosing Period)
    • Plasma and urine PK parameters assessed for each dose of APD418 baseline, end of infusion at 6-hours, and intermediate timepoints during
    6-hour infusion, as well as post-infusion timepoints
    • Safety and tolerability of APD418 by incidence of all treatment-emergent adverse events (TEAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, end of infusion at 6-hours, intermediate timepoints during 6-hour infusion
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Serbia
    United States
    Germany
    Greece
    Poland
    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
    End of Study is defined as completion of the final Follow-Up phone call for the last subject.
    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 months7
    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 months7
    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.1.2.1Number of subjects for this age range: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 80
    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)
    Patients will continue on standard of care.
    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 Decision2021-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-09-10
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