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

Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Sonazoid™

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Chaoyang, Beijing, China
      • Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Drug: Sonazoid™; Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.; Other Names: perfluorobutane
EXPERIMENTAL: Sonazoid™ 0.60 µl; Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight.	Drug: Sonazoid™; Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.; Other Names: perfluorobutane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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 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
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
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
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
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
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
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Vital Signs	Up to 4 hours post dose
Percentage of Participants With Injection Site Reactions	Up to 4 hours post dose
Percentage of Participants With Abnormal Physical Examinations	Up to 4 hours post dose

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2014
• Primary Completion (ACTUAL): November 20, 2014
• Study Completion (ACTUAL): November 20, 2014

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (ACTUAL): November 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 8, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: GE-045-001 (OTHER: GE HealthCare)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No