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

November 8, 2017 updated by: GE Healthcare

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Rate Constant (kel) in Blood
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Half-life (t½) in Blood
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Clearance (Cl) in Blood
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Maximum Observed Concentration (Cmax) in Blood
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Volume of Distribution (Vd) in Blood
Time Frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose
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
Time Frame: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants With Treatment-Related Adverse Events (AEs)
Time Frame: Up to 72 hours after first administration of investigational medicinal product (IMP)
Up to 72 hours after first administration of investigational medicinal product (IMP)
Percentage of Participants With Abnormal Laboratory Values
Time Frame: Up to 4 hours post dose
Up to 4 hours post dose
Percentage of Participants With Abnormal Vital Signs
Time Frame: Up to 4 hours post dose
Up to 4 hours post dose
Percentage of Participants With Injection Site Reactions
Time Frame: Up to 4 hours post dose
Up to 4 hours post dose
Percentage of Participants With Abnormal Physical Examinations
Time Frame: Up to 4 hours post dose
Up to 4 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GE Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Sonazoid™

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings