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    Summary
    EudraCT Number:2006-003012-21
    Sponsor's Protocol Code Number:AI-700-34
    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:2006-11-23
    Trial 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 number2006-003012-21
    A.3Full title of the trial
    A Phase 3, International, Exploratory, Open-Label, Multicenter, Dual-Injection, Echocardiographic Imaging Settings and Safety Study of AI-700 in Normal Volunteers and Stable Cardiac Patients (Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study)
    A.3.2Name or abbreviated title of the trial where available
    ACCESS
    A.4.1Sponsor's protocol code numberAI-700-34
    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 SponsorAcusphere, 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 namePerflubutane Polymer Microspheres Injectable Suspension
    D.3.2Product code AI-700
    D.3.4Pharmaceutical form Powder for suspension for injection
    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 INNPerflubutane
    D.3.9.1CAS number 355-25-9
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive namePerfluorobutane, Decafluorobutane
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number36 mg/mL to 44 mg/mL
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    AI-700 is an intravenous (IV) ultrasound contrast agent designed for echocardiographic imaging for myocardial defect detection.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10061024
    E.1.2Term Cardiac disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of the study are:

    1) to evaluate and optimize settings for AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms;

    2) to evaluate the performance of AI-700 for echocardiographic imaging on several ultrasound imaging platforms; and

    3) to collect additional safety data for AI-700 in healthy volunteers and stable cardiac patients.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Up to 60 men and non-pregnant/non-lactating women who are 18 to 70 years of age and who have undergone echocardiographic imaging within 14 days before AI-700 administration will be enrolled. The study will include both healthy volunteers and stable cardiac patient candidates.

    Inclusion Criteria – Healthy Volunteers

    • Male or female between 18 and 70 years of age;
    • In good health, as determined by medical history, physical examination, vital signs, and 12-lead ECG;
    • If female, must be at least 1 year post-menopausal or surgically sterile; or be sexually abstinent or have a sterile sexual partner; or from 4 weeks before dosing until 30 days post-dosing use oral, implantable, or injectable contraceptives or an approved form of contraception (including intrauterine device [IUD], female condom, diaphragm with spermicidal, cervical cap, or use of a condom by sexual partner);
    • If female, have a negative serum pregnancy test within 24 hours of AI-700 if pre-menopausal or <1 year post menopausal;
    • Willingness to provide the Sponsor with access to data associated with his/her Qualification Echo performed during the 14 days prior to AI-700 dosing;
    • Able to comprehend and willing to sign an informed consent form;
    • Must have a low chance of coronary artery disease (CAD) as defined by medical history, ECG, the Qualification Echo, CAD risk factors, and (if available) a negative nuclear imaging study and/or a negative ECG stress test.

    Inclusion Criteria – Stable Cardiac Patients

    • Male or female and 18 to 70 years of age;
    • In stable health, as determined by medical history, physical examination, vital signs, and 12 lead ECG;
    • History of myocardial infarction (MI) and/or coronary artery revascularization procedure at least 90 days prior to AI-700 dosing;
    • Willingness to provide the Sponsor with access to data associated with his/her Qualification Echo performed during the 14 days prior to AI-700 dosing;
    • If female, must be at least 1 year post-menopausal or surgically sterile; or be sexually abstinent or have a sterile sexual partner; or from 4 weeks before dosing until 30 days post-dosing use oral, implantable, or injectable contraceptives or an approved form of contraception (including intrauterine device (IUD), female condom, diaphragm with spermicidal, cervical cap, or use of a condom by sexual partner);
    • If female, have a negative serum pregnancy test within 24 hours of AI-700 if pre-menopausal or <1 year post-menopausal;
    • Able to comprehend and willing to sign an informed consent form.
    E.4Principal exclusion criteria
    Exclusion Criteria - Healthy Volunteers

    • Significant intra-cardiac shunt or any other cardiovascular structural and/or severe functional abnormality on the Qualification Echo, unless deemed not clinical relevant by the Investigator and approved by the Sponsor in writing;
    • Ejection fraction (EF, estimated from Qualification Echo) ≤55% (outside normal range);
    • Oxygen saturation <92% at rest;
    • Females who are pregnant or lactating;
    • A history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes;
    • A history of any major surgical procedure within 90 days of Screening/Baseline;
    • Body mass index (BMI) >35;
    • Inadequate visualization of 3 or more segments in the 4-chamber apical view for evaluation of cardiac function during the Qualification Echo;
    • Sitting systolic blood pressure <90 mmHg or >150 mmHg, diastolic blood pressure <50 mmHg or >95 mmHg, pulse rate <45 bpm or >90 bpm;
    • Frequent PVCs or PACs (defined as >5 PVCs and/or PACs per minute);
    • Any ≥2nd AV block, bundle branch block (BBB), or rhythm abnormality;
    • History of non-seasonal asthma within the past 3 years or a recent history of seasonal asthma requiring prescription medications to control;
    • Participated in a clinical study involving an investigational drug or device within 30 days prior to AI-700 administration (90 days for subjects in the UK);
    • Previous participation in an AI-700 clinical trial

    Exclusion Criteria – Stable Cardiac Patients

    • Any clinically unstable condition documented within 30 days prior to AI-700 administration or at Screening/Baseline. These conditions include, but are not limited to: severe arterial hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >120 mmHg) or pulmonary hypertension (>60 mmHg systolic), or any increase in pulmonary pressures felt to be due to increased pulmonary vascular resistance; hypotension (sitting systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg); bradycardia or tachycardia (pulse rate <45 bpm or >100 bpm); history of any major surgical procedure; or exacerbation of chronic obstructive pulmonary disease (COPD) of any severity, irrespective of hospitalization.
    • Recent history (past 6 months) of typical or atypical chest pain (angina), or unstable angina;
    • Congestive heart failure (CHF) graded as New York Heart Association Class 3 or 4 within 90 days of dosing;
    • COPD, with FEV1<50% of predicted, FEV1/FVC<75% of predicted, measured within 6 months prior to dosing;
    • Significant left main coronary artery disease (≥50% stenosis), if known;
    • Any revascularization procedure within 90 days prior to AI-700 administration;
    • Female who is pregnant or lactating;
    • Cerebrovascular accident or transient ischemic attack within 90 days prior to AI-700 administration;
    • Significant cardiovascular structural abnormality, including intra-cardiac shunts; uncorrected congenital heart disease (i.e., patent foramen ovale); idiopathic, severe valvular disease; large amount of pericardial effusion; as determined by the Qualification Echo, unless deemed not clinically significant by the Investigator and approved by the Sponsor;
    • EF (estimated from Qualification Echo) <40 %;
    • Inadequate visualization of 3 or more segments in the 4-chamber apical view for evaluation of cardiac function during the Qualification Echo;
    • Oxygen saturation <90% at rest;
    • Uncontrolled atrial fibrillation or frequent premature ventricular contractions (PVCs) or premature atrial contractions (PACs) (defined as >5 PVCs and/or PACs per minute);
    • History of QT/QTc prolongation (QT/QTc >500 msec);
    • New or changing ECG abnormalities at any time between Screening and AI-700 dosing;
    • Any ≥2nd AV block, BBB, or rhythm abnormality that has not been evaluated and treated by a specialist or for which current treatment is not adequately effective to the extent that subject safety is assured;
    • Use of automatic implantable cardioverter/defibrillator;
    • History of non-seasonal asthma within the past 3 years or a recent history of seasonal asthma requiring prescription medications to control;
    • Organ transplant or end-stage failure of a major organ;
    • Active seizure disorder and/or any episode of seizure in the past 6 months;
    • Participated in a clinical study involving an investigational drug or device within 30 days prior to AI 700 administration (90 days for subjects in the UK);
    • Significant pulmonary structural or functional abnormality (e.g. lobectomy of the lung);
    • Previous participation in an AI-700 clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    The main objective of this study is to explore AI-700 imaging techniques on several platforms not yet tested. No statistical efficacy analyses will be performed. The performance of AI-700 Echo contrast with regards to myocardial contrast enhancement will be evaluated using different ultrasound platforms. The analyses will be based on review of the imaging data by the Sponsor/designee. Any patient who receives AI-700 will have images reviewed, irrespective of the quality and/or completeness of the data.

    Safety will be assessed based on a review of adverse events, clinical laboratory evaluations (hematology, coagulation, and serum chemistry), vital signs monitoring (including pulse oximetry), ECGs, US-ECGs, injection site monitoring, review of concomitant medications, and physical examinations. When blood sample collections and other safety assessments (vital signs, 12-lead ECG, etc.) occur at the same timepoint, ECG and vital signs will be collected first at the scheduled timepoints, and other safety assessments will be performed after collection of the blood sample. Additional safety assessments will be acquired for any subject for whom it is deemed necessary (e.g., for an AE) by the Investigator.
    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 No
    E.6.7Pharmacodynamic No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 trial will be completed at the follow-up visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    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)
    N/A
    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 Decision2006-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-03-06
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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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