Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
| Registry | NCT03340870 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; non randomized, parallel, masking: none, other |
| Enrollment | 16 (Actual) |
| Sponsor | GE Healthcare (Industry) |
| Conditions | Healthy |
| Interventions | Sonazoid™ (Drug) |
| Dates | start 2014-10-20, primary completion 2014-11-20, completion 2014-11-20, first posted 2017-11-14, last updated 2017-11-14 |
| Locations | 1 site in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sonazoid™ 0.12 microliter (µl) | Experimental | Drug: Sonazoid™ | Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight. |
| Sonazoid™ 0.60 µl | Experimental | Drug: Sonazoid™ | Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight. |
Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu | Chaoyang, Beijing Municipality | China |