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| ID | Type | Description | Link |
|---|---|---|---|
| GE-045-001 | Other Identifier | GE HealthCare |
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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 Sonazoidâ„¢ in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Sonazoid™ 0.60 µl | Experimental | Participants will receive single I.V bolus injection of Sonazoid™ 0.60 µl MB/kg body weight. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sonazoidâ„¢ | Drug | Single Dose of Sonazoidâ„¢ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles. |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Tranquart, MD, PhD | GE Healthcare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University, NO. 8 Gongren Tiyuchang Nanlu | Chaoyang | Beijing Municipality | China |
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| ID | Term |
|---|---|
| C069727 | Sonazoid |
| C108042 | perfluorobutane |
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| 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 |
| 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 |