A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: Sonazoid™
- Registration Number
- NCT03340870
- Lead Sponsor
- GE Healthcare
- 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 volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sonazoid™ 0.12 microliter (µl) 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 Sonazoid™ Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight.
- Primary Outcome Measures
Name Time Method Elimination Rate Constant (kel) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-infinity∞) After Single Dose in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Area Under the Concentration Versus Time Curve from Time Zero to the Last Time- Point (AUC 0-last), AUC from Time Zero to Infinity (AUC0-Infinity∞) After Single Dose in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Elimination Half-life (t½) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Volume of Distribution (Vd) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Elimination Rate Constant (kel) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Volume of Distribution (Vd) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Elimination Half-life (t½) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Clearance (Cl) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Clearance (Cl) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Maximum Observed Concentration (Cmax) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Time at which Cmax is reached (tmax) in Blood Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose Time at which Cmax is reached (tmax) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose Maximum Observed Concentration (Cmax) in Exhaled Air Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Treatment-Related Adverse Events (AEs) Up to 72 hours after first administration of investigational medicinal product (IMP) Percentage of Participants With Abnormal Laboratory Values Up to 4 hours post dose Percentage of Participants With Abnormal Physical Examinations Up to 4 hours post dose Percentage of Participants With Abnormal Vital Signs Up to 4 hours post dose Percentage of Participants With Injection Site Reactions Up to 4 hours post dose
Trial Locations
- Locations (1)
Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
🇨🇳Chaoyang, Beijing, China
Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu🇨🇳Chaoyang, Beijing, China