Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Elimination Rate Constant (kel) in Exhaled Air
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sonazoid™ (Drug)
Sonazoid™ 0.60 µl
Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight.
干预措施: Sonazoid™ (Drug)
结局指标
主要结局
Elimination Rate Constant (kel) in Exhaled Air
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Volume of Distribution (Vd) in Blood
时间窗: 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
时间窗: 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
时间窗: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Clearance (Cl) in Blood
时间窗: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Exhaled Air
时间窗: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Half-life (t½) in Blood
时间窗: 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
时间窗: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Maximum Observed Concentration (Cmax) in Blood
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
次要结局
- Percentage of Participants With Abnormal Laboratory Values(Up to 4 hours post dose)
- 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 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)