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| Name | Class |
|---|---|
| Medpace, Inc. | INDUSTRY |
| i3 Statprobe | INDUSTRY |
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This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (AH113111 Injection) | Experimental |
| |
| 2 (Visipaque Injection) | Active Comparator | An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GE-145 (AN113111) Injection | Drug | 40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours. | Baseline and up to and including 72 hours post contrast administration |
| Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic and Diastolic bolld pressure taken up to and including 8 hours | Baseline and up to and including 8 hours post contrast administation. |
| Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours. | Baseline and up to and including 8 hours post contrast administration |
| 12-Lead Electrocardiogram (ECG) Values | 12-Lead ECG values taken up to and including 24 hours | Baseline and up to and including 24 hours post contrast administration |
| Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase | Pre and post contrast administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rubin Sheng, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | GE-145 Injection-300mg of Iodine/mL | GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose. |
| FG001 | GE-145 Injection-450mg of Iodine/mL |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Visipaque (iodixanol) Injection | Drug | An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg. |
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GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
| FG002 | GE-145 Injection-600mg of Iodine/mL | GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose. |
| FG003 | GE-145 Injection-900mg of Iodine/mL | GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose. |
| FG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GE-145 Injection-300mg of Iodine/mL | GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose. |
| BG001 | GE-145 Injection-450mg of Iodine/mL | GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose. |
| BG002 | GE-145 Injection-600mg of Iodine/mL | GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose. |
| BG003 | GE-145 Injection-900mg of Iodine/mL | GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose. |
| BG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours. | Per Study Protocol | Posted | Mean | Standard Deviation | mg/dL | Baseline and up to and including 72 hours post contrast administration |
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| Primary | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic and Diastolic bolld pressure taken up to and including 8 hours | Per Study Protocol | Posted | Mean | Standard Deviation | mm Hg | Baseline and up to and including 8 hours post contrast administation. |
| |||||||||||||||||||||||||||||||||||||||
| Primary | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours. | Per Study Protocol | Posted | Mean | Standard Deviation | > 10 beats per minute (bpm) | Baseline and up to and including 8 hours post contrast administration |
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| Primary | 12-Lead Electrocardiogram (ECG) Values | 12-Lead ECG values taken up to and including 24 hours | Per Study Protocol | Posted | Mean | Standard Deviation | QTcB (msec) | Baseline and up to and including 24 hours post contrast administration |
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| Primary | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase | Per Study Protocol | Posted | Mean | Standard Deviation | Hounsfield Units | Pre and post contrast administration |
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7 Day Followup
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GE-145 Injection-300mg of Iodine/mL | GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose. | 0 | 10 | 2 | 10 | ||
| EG001 | GE-145 Injection-450mg of Iodine/mL | GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose. | 1 | 10 | 1 | 10 | ||
| EG002 | GE-145 Injection-600mg of Iodine/mL | GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose. | 0 | 10 | 0 | 10 | ||
| EG003 | GE-145 Injection-900mg of Iodine/mL | GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose. | 0 | 10 | 0 | 10 | ||
| EG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg | 0 | 10 | 0 | 10 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Radiation Exposure | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment | Patient received radiation exposure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Gastrointestinal | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rubin Sheng, MD | GE Healthcare | 1-609-514-6899 | rubin.sheng@ge.com |
| ID | Term |
|---|---|
| C553686 | 5-(formyl-(3-(formyl-(3,5-bis (2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl) amino)-2-hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide |
| D007267 | Injections |
| C044834 | iodixanol |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| BUN - 8 h post |
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| BUN - 24 h post |
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| BUN - 48 h post |
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| BUN - 72 h post |
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| Creatinine - Baseline |
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| Creatinine - 8 h post |
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| Creatinine - 24 h post |
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| Creatinine - 48 h post |
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| Creatinine - 72 h post |
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| OG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
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| OG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
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| OG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
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| OG004 | Visipaque Injection | Visipaque x 320mgI/mL at a dose of 450mgI/kg |
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