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Also known as Ioforminol
Ioforminol 160 mgI/mL · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Ioforminol 160 mgI/mL | DRUG | Given as s single administration to the subject |
| 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 |
Inclusion Criteria: * Healthy males or females between 18 and 50 years of age. * The subject has a maximum abdominal circumference of 120 cm or less. Exclusion Criteria: * The subject has known Grade 3 or 4 allergic reaction/hypersensitivity to either iodine or any iodinated-based contrast agent ...
Ioforminol 160 mgI/mL is an investigational small molecule contrast agent being developed by GE HealthCare Technologies Inc. It is a low concentration formulation of ioforminol intended for use in abdominal contrast-enhanced computed tomography (CECT) imaging. It remains in clinical development and is not approved for commercial use.
Ioforminol 160 mgI/mL is being developed by GE HealthCare Technologies Inc., which trades on the Nasdaq under the ticker GEHC. GE HealthCare is the sponsor of the clinical program evaluating this low concentration ioforminol formulation for contrast-enhanced abdominal CT imaging.
Ioforminol 160 mgI/mL is in Phase 1 clinical development. The program has completed one Phase 1 trial to date, with no active trials currently listed. As an investigational agent, it has not been approved by the FDA or any other regulatory authority for commercial use.
Ioforminol 160 mgI/mL has been studied in one completed Phase 1 trial, NCT01672996, titled an open label, randomized study of low concentration ioforminol injections for use in abdominal CECT in healthy volunteers. The trial enrolled 66 healthy adult participants in the United States and used an active-controlled design.
The Phase 1 trial NCT01672996 was an open label, randomized, active-controlled study evaluating low concentration ioforminol injections for abdominal contrast-enhanced CT in healthy volunteers. It enrolled 66 participants of all sexes, aged 18 years and older, across sites in the United States, and the trial is now completed.