A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
NCT ID: NCT03340870
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2014-10-20
2014-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Sonazoid™ 0.12 microliter (µl)
Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight.
Sonazoid™
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
Sonazoid™ 0.60 µl
Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight.
Sonazoid™
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
Interventions
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Sonazoid™
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant is male, or a female who was either surgically sterile (has a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of Sonazoid™ administration (with the result known before IMP administration), were negative
* Participant is able and willing to comply with study procedures and provide signed and dated informed consent
* Participant has a body mass index of 19 to 26
* Participant has agreed not to smoke from 2 hours before to 5 hours after Sonazoid™ administration
* Participant has agreed to avoid strenuous physical activity from 1 week before Sonazoid™ administration until the end of the study follow-up
* Participant has no history of alcohol or substance abuse, and has agreed to no intake of alcohol or drugs for 48 hours before Sonazoid™ administration and until the end of the study follow-up
* Participant has a normal health status, as judged by medical history and physical examination at screening
* Normal 12-lead electrocardiogram (ECG) at screening. Minor abnormalities considered by the investigator to be of no clinical importance are permitted
* Normal blood and urine clinical chemistry variables at screening. Isolated or minimally out-of-range values considered by the investigator to be of no clinical importance are permitted
* No regular use of concomitant medication, except for routine use of supplemental oestrogen
Exclusion Criteria
* Participation in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
* Participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral and laryngeal swelling, hypotension or shock)
* Donation of \>500 milliliter (mL) blood in the 12 weeks before Sonazoid™ administration
* Participant with congenital heart defects, including right-to-left, bi-directional, or transient right-to-left cardiac shunts
* Participant has positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus
18 Years
45 Years
ALL
Yes
Sponsors
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GE Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Francois Tranquart, MD, PhD
Role: STUDY_CHAIR
GE Healthcare
Locations
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Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
Chaoyang, Beijing Municipality, China
Countries
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Other Identifiers
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GE-045-001
Identifier Type: OTHER
Identifier Source: secondary_id
GE-045-001
Identifier Type: -
Identifier Source: org_study_id