Clinical trial NCT03340870: A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
Official title: Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2017-11-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: 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
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Percentage of the Extrapolated Area to Total Area (% AUC ext) After Single Dose in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Elimination Rate Constant (kel) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Elimination Rate Constant (kel) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Elimination Half-life (t½) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Elimination Half-life (t½) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Clearance (Cl) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Clearance (Cl) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Maximum Observed Concentration (Cmax) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Maximum Observed Concentration (Cmax) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Time at which Cmax is reached (tmax) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Time at which Cmax is reached (tmax) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
measure: Volume of Distribution (Vd) in Blood
timeFrame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
measure: Volume of Distribution (Vd) in Exhaled Air
timeFrame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Secondary outcomes:
measure: Percentage of Participants With Treatment-Related Adverse Events (AEs)
timeFrame: Up to 72 hours after first administration of investigational medicinal product (IMP)
measure: Percentage of Participants With Abnormal Laboratory Values
timeFrame: Up to 4 hours post dose
measure: Percentage of Participants With Abnormal Vital Signs
timeFrame: Up to 4 hours post dose
measure: Percentage of Participants With Injection Site Reactions
timeFrame: Up to 4 hours post dose
measure: Percentage of Participants With Abnormal Physical Examinations
timeFrame: Up to 4 hours post dose
Other outcomes:
Locations:
city: Chaoyang
country: China
facility: Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
state: Beijing
Study officials:
affiliation: GE Healthcare
name: Francois Tranquart, MD, PhD
role: STUDY_CHAIR
References: