An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers (NCT03882359) | Clinical Trial Compass
CompletedPhase 1/2
An Ascending Dose Comparison of MVT-100 to Definity in Healthy Volunteers
United States16 participantsStarted 2019-04-25
Plain-language summary
Definity (perflutren lipid microspheres, Lantheus Medical Imaging) is an ultrasound contrast indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. MVT-100 (the investigational pharmaceutical) is similar to Definity, with the exception of the removal of one lipid in the lipid blend and substitution of another lipid. This study is intended to evaluate the safety and efficacy of MVT-100 using a single ascending dose design in healthy volunteers. Patients are randomized to receive either MVT-100 or Definity and undergo echocardiograms after receiving either MVT-100 or Definity via bolus or IV infusion administration. The primary endpoints evaluated are safety and endocardial border delineation.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult subjects 19 years of age or older, male or female
* Female subjects must no longer have child-bearing potential (\>1-year post menopause or surgically sterilized), or must
* have a negative urine pregnancy test, and
* be using and continue to use for 30 days after the study a medically effective method of contraception
* Adequate hematologic, renal and hepatic function, as defined by:
* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
* Platelet count ≥ 100 x 109/L
* Hemoglobin ≥ 90 g/L
* Plasma creatinine\< 1.5 x ULN
* Total bilirubin within normal limits (\< 2.5 x ULN if Gilbert's syndrome)
* Aspartate transaminase (AST) and Alanine transaminase (ALT) \< 2.5 x ULN
* Subject must be willing and able to understand the study and provide written Informed Consent to participate in the study
Exclusion Criteria:
* Myocardial infarction within six months prior to enrollment
* Unstable angina, NYHA Class II or greater congestive heart failure
* EKG evidence of uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six months
* Clinically significant Chronic Obstructive Pulmonary Disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously
* A history of pulmonary emboli
* Known hypersensitivity to perflutren, DEFINITY® or other echo contrast agent
* Inability to remain supine for 60 minutes
* Oxygen saturation \< 95% on room air
* History of allergic re…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.