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Ioforminol 160 mgI/mL

Phase 1

Healthy | Small molecule | Other |GE HealthCare Technologies Inc.|Last Updated: May 29, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Ioforminol 160 mgI/mL · 1 trial · 1 indication

Phase 1 1
NCT01672996Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy VolunteersHealthy
COMPLETED66 Analytics
PHASE1COMPLETED
Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

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).
Within 5 minutes after administration for either Ioforminol or Iopamidol.

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.

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).
Within 5 minutes after administration for either Ioforminol or Iopamidol.

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.

Secondary Endpoints

Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE).
Up to 72 hours for safety monitoring post Ioforminol and Iopamidol administration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Arm 1 - Ioforminol 160mgI/mLEXPERIMENTALSingle administration of Ioforminol 160mgI/mL given to the subject.
Arm 2 - Ioforminol 200mgI/mLEXPERIMENTALGiven as a single administration to the subject
Arm 3 - Iopamidol 300mgI/mLACTIVE_COMPARATORGiven as a single administration to the subject

Interventions

NameTypeDescription
Ioforminol 160 mgI/mLDRUGGiven as s single administration to the subject
Ioforminol 200 mgI/mLDRUGGiven as a single administration to the subject
Iopamidol 300 mgI/mLDRUGGiven as a single administration to the subject
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 ...

Countries:United States
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Frequently asked questions about Ioforminol 160 mgI/mL

What is Ioforminol 160 mgI/mL used for?

Ioforminol 160 mgI/mL is an investigational small molecule being studied for use in abdominal contrast-enhanced computed tomography (CECT) in healthy volunteers. It is a low-concentration iodine-based contrast agent intended for imaging applications. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes Ioforminol 160 mgI/mL?

Ioforminol 160 mgI/mL is being developed by GE HealthCare Technologies Inc., a company traded on the New York Stock Exchange under the ticker GEHC. The company is conducting clinical research to evaluate this contrast agent for use in abdominal imaging procedures.

What phase is Ioforminol 160 mgI/mL in?

Ioforminol 160 mgI/mL is in Phase 1 clinical development. It is an investigational drug that has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains under investigation for its intended use in abdominal contrast-enhanced computed tomography.

What clinical trials is Ioforminol 160 mgI/mL in?

Ioforminol 160 mgI/mL has one completed Phase 1 clinical trial registered as NCT01672996. This open-label, randomized study evaluated low concentration Ioforminol injections for use in abdominal CECT in healthy volunteers. The trial enrolled 66 participants in the United States and was actively controlled.

Is Ioforminol 160 mgI/mL the same as other contrast agents?

Ioforminol 160 mgI/mL is a distinct investigational contrast agent developed by GE HealthCare. It is formulated at a low iodine concentration of 160 mgI/mL for use in imaging procedures. No alternative names for this specific drug have been disclosed in clinical trial registrations.