AI-700 is an intravenous (IV) ultrasound contrast agent designed for echocardiographic imaging for myocardial defect detection. MedDRA version: 8.1 Level: LLT Classification code 10061024 Term: Cardiac disorder
Conditions
Interventions
Product Name: Perflubutane Polymer Microspheres Injectable Suspension
Product Code: AI-700
Pharmaceutical Form: Powder for suspension for injection
INN
Sponsors
Acusphere, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 150 mmHg, diastolic blood pressure 95 mmHg, pulse rate 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 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 valvul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: ; Primary 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. | — |
Countries
United Kingdom
Outcome results
None listed