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

Healthy Clinical Trial

Official title:

Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03340870
• Other study ID #: GE-045-001
• Secondary ID: GE-045-001
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2017
• Last updated: November 8, 2017
• Start date: October 20, 2014
• Est. completion date: November 20, 2014

Study information

• Verified date: November 2017
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 20, 2014
• Est. primary completion date: November 20, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Sonazoid™
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.

Locations

Country	Name	City	State
China	Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu	Chaoyang	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-infinity8) 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
Primary	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-Infinity8) After Single Dose in Exhaled Air		Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Clearance (Cl) in Blood		Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
Primary	Clearance (Cl) in Exhaled Air		Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage of Participants With Treatment-Related Adverse Events (AEs)		Up to 72 hours after first administration of investigational medicinal product (IMP)
Secondary	Percentage of Participants With Abnormal Laboratory Values		Up to 4 hours post dose
Secondary	Percentage of Participants With Abnormal Vital Signs		Up to 4 hours post dose
Secondary	Percentage of Participants With Injection Site Reactions		Up to 4 hours post dose
Secondary	Percentage of Participants With Abnormal Physical Examinations		Up to 4 hours post dose