A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

General Electric (GE)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Sonazoid™

Study type

Interventional

Funder types

Industry

Identifiers

NCT03340870

GE-045-001 (Other Identifier)

Details and patient eligibility

About

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 volunteers.

Enrollment

16 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: 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 Criteria:

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