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| Name | Class |
|---|---|
| Physician Reference Laboratory | UNKNOWN |
| Quintiles, Inc. | INDUSTRY |
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To optimize both the Ioforminol concentration and dosage(s) for CECT of the abdomen. To evaluate the safety and tolerability of low concentration Ioforminol Injections. Study recruits healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Ioforminol 160mgI/mL | Experimental | Single administration of Ioforminol 160mgI/mL given to the subject. |
|
| Arm 2 - Ioforminol 200mgI/mL | Experimental | Given as a single administration to the subject |
|
| Arm 3 - Iopamidol 300mgI/mL | Active Comparator | Given as a single administration to the subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ioforminol 160 mgI/mL | Drug | Given as s single administration to the subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Within 5 minutes after administration for either Ioforminol or Iopamidol. |
| Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Within 5 minutes after administration for either Ioforminol or Iopamidol. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Recording the occurrence of treatment emergent adverse events (TEAE). | Up to 72 hours for safety monitoring post Ioforminol and Iopamidol 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 | Arm 1 - Ioforminol 160mgI/mL | Single administration of Ioforminol 160mgI/mL given to the subject. Ioforminol 160 mgI/mL: Given as s single administration to the subject |
| FG001 | Arm 2 - Ioforminol 200mgI/mL | Given as a single administration to the subject Ioforminol 200 mgI/mL: Given as a single administration to the subject |
| FG002 | Arm 3 - Iopamidol 300mgI/mL | Given as a single administration to the subject Iopamidol 300 mgI/mL: Given as a single administration to the subject |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg. |
| BG001 | Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 80 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Evaluted 33 subjects using 80 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. | Posted | Mean | Standard Deviation | Hounsfield Units | Within 5 minutes after administration for either Ioforminol or Iopamidol. |
|
Up to 72 hours post Ioforminal or Iopamidol administration.
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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 | Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.0mL/kg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rubin Sheng, MD | GE Healthcare | 609-514-6899 | Rubin.Sheng@ge.com |
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| ID | Term |
|---|---|
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Ioforminol 200 mgI/mL | Drug | Given as a single administration to the subject |
|
|
| Iopamidol 300 mgI/mL | Drug | Given as a single administration to the subject |
|
|
Ioforminol 160 mgI/mL: Given as s single administration to the subject.
Dosing the Subject at 1.5mL/kg.
| BG002 | Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg. |
| BG003 | Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg |
| BG004 | Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg |
| BG005 | Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg |
| BG006 | Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG001 | Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg. |
| OG002 | Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg. |
| OG003 | Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg |
| OG004 | Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg |
| OG005 | Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg |
| OG006 | Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg |
|
|
| Secondary | Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). | Recording the occurrence of treatment emergent adverse events (TEAE). | These are the numbers of Treatment Emergent Adverse Events (TEAE) and TEAEs related to Investigational Medicinal Product (IMP). | Posted | Number | Adverse Events | Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration. |
|
|
|
| Primary | Radiographic Densities at Selected Regions in Contrast-enhanced CT Examination by Location (Abdominal Aorta), kVp 100 and Contrast Type (Ioforminol vs Iopamidol), Concentration (Ioforminol 160 or 200) and Dose Levels (1.0, 1.5, and 2.0mL/kg). | Quantitative measurement of the radiographic density (as measured by Hounsfield Units (HU) ) at the abdominal aorta at the level of the celiac artery. The greater the contrast attenuation, the higher the HU. | Evaluted 33 subjects using 100 kilovolt peak (kVp), a measure of the maximum electrical potential in kilovolts across an x-ray. tube. | Posted | Mean | Standard Deviation | Hounsfield Units | Within 5 minutes after administration for either Ioforminol or Iopamidol. |
|
|
|
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 1.5mL/kg. | 0 | 10 | 5 | 10 |
| EG002 | Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg | Ioforminol 160 mgI/mL: Given as s single administration to the subject. Dosing the Subject at 2.0mL/kg. | 0 | 10 | 10 | 10 |
| EG003 | Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg | 0 | 10 | 8 | 10 |
| EG004 | Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.5mL/Kg | 0 | 10 | 5 | 10 |
| EG005 | Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg | Ioforminol 200 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 2.0mL/Kg | 0 | 10 | 7 | 10 |
| EG006 | Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg | Iopamidol 300 mgI/mL: Given as a single administration to the subject. Dosing the Subject at 1.0mL/Kg | 0 | 6 | 5 | 6 |
| Feeling Hot | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Any Treatment Emergent Adverse Events-IMP |
|
| Intensity-Mild |
|
| Serious TEAEs |
|
| Withdrawals due to Adverse Events |
|
| Deaths |
|