Status:
COMPLETED
A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
Lead Sponsor:
GE Healthcare
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to determine the Pharmacokinetics (PK) data of perfluorobutane (PFB) in blood and exhaled air following intravenous (I.V.) bolus injection of Sonazoid™ in healthy ...
Eligibility Criteria
Inclusion
- Participants may be included in the study if they meet all of the following criteria:
- Participant is between 18 and 45 years of age
- 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
- Participant was previously included in this study
- 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
Key Trial Info
Start Date :
October 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03340870
Start Date
October 20 2014
End Date
November 20 2014
Last Update
November 14 2017
Active Locations (1)
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1
Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
Chaoyang, Beijing Municipality, China