HealthyPhase 1NCT03340870
A Study to Evaluate Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
A Phase 1 study testing Sonazoid™ in people with Healthy, run by GE Healthcare at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sonazoid™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2014to 20 Nov 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu
Chaoyang, Beijing Municipality
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Sonazoid™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonazoid™Drug
Also called perfluorobutane
Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
| Study group | Role | What they receive |
|---|---|---|
| Sonazoid™ 0.12 microliter (µl) | Experimental | Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight. Receives: Drug: Sonazoid™ |
| Sonazoid™ 0.60 µl | Experimental | Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight. Receives: Drug: Sonazoid™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Rate Constant (kel) in Blood
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Elimination Half-life (t½) in Blood
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Clearance (Cl) in Blood
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Maximum Observed Concentration (Cmax) in Blood
Measured: 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
Measured: 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
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Volume of Distribution (Vd) in Blood
Measured: 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
Measured: Pre dose and at 1, 3, 6, 9, 16, 31, 61, 121 minutes and 4 hours post dose
Secondary outcomes (5)
Percentage of Participants With Treatment-Related Adverse Events (AEs)
Measured: Up to 72 hours after first administration of investigational medicinal product (IMP)
Percentage of Participants With Abnormal Laboratory Values
Measured: Up to 4 hours post dose
Percentage of Participants With Abnormal Vital Signs
Measured: Up to 4 hours post dose
Percentage of Participants With Injection Site Reactions
Measured: Up to 4 hours post dose
Percentage of Participants With Abnormal Physical Examinations
Measured: Up to 4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start20 Oct 2014
- Primary completion20 Nov 2014
- Study completion20 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francois Tranquart, MD, PhD, Study chair, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340870
- Sponsor's protocol ID
- GE-045-001
- Other IDs
- GE-045-001
- Status last verified
- Nov 2017
- First submitted
- 2 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Sonazoid™ Following Intravenous Bolus Injection in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03340870
- Acronym / sponsor ID
- GE-045-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 20 Nov 2014 (actual)
- Study completion
- 20 Nov 2014 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonazoid™ 0.12 microliter (µl) | Experimental | Drug: Sonazoid™Participants will receive single intravenous (I.V) bolus injection of Sonazoid™ 0.12 µl microbubbles (MB)/kilogram (kg) body weight. |
| Sonazoid™ 0.60 µl | Experimental | Drug: Sonazoid™Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonazoid™Also: perfluorobutaneSingle Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles. | Drug | Sonazoid™ 0.12 microliter (µl), Sonazoid™ 0.60 µl |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
5 secondary outcomes
Percentage of Participants With Treatment-Related Adverse Events (AEs)
Time frame: 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
Percentage of Participants With Abnormal Vital Signs
Time frame: Up to 4 hours post dose
Percentage of Participants With Injection Site Reactions
Time frame: Up to 4 hours post dose
Percentage of Participants With Abnormal Physical Examinations
Time frame: Up to 4 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Tranquart, MD, PhD study chair
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sonazoid™ in people with Healthy, run by GE Healthcare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Pre dose and at 0.5, 1, 2, 5, 10, 15, 30, 60, 120 minutes and 4 hours post dose). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.