Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers

• Ioforminol 160 mgI/mL (Drug), also known as Ioforminol: Given as s single administration to the subject
• Ioforminol 200 mgI/mL (Drug), also known as Ioforminol: Given as a single administration to the subject
• Iopamidol 300 mgI/mL (Drug), also known as Iopamidol, Isovue 300, Isovue: Given as a single administration to the subject

Primary outcomes

• 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 outcomes

• 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.]: Recording the occurrence of treatment emergent adverse events (TEAE).

Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers

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 or with history of multiple allergies (i.e., foods, pets, medications, etc).
* The subject has chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] <60 mg/dL) as measured at the screening visit.
* The subject is pregnant or breast-feeding.
* The subject has suspicion or diagnosis of hyperthyroidism or autonomously functioning thyroid nodule confirmed by T3, T4, and/or thyroid-stimulating hormone.
* The subject has severe liver or hematologic diseases (sickle cell disease or multiple myeloma), or immunodeficiency.
* The subject is taking metformin (e.g., Glucophage®) therapy.

Participant flow

Outcome results

• 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). (Primary), Mean, Hounsfield Units: Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg 168 +/- 41.0; Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg 261 +/- 56.5; Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg 345 +/- 30.7; Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg 341 +/- 33.6; Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg 357 +/- 30.1; Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg 365 +/- 67.7; Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg 331 +/- 53.7
• Evaluate the Overall Safety of Ioforminol and Iopamidol Injections by Recording Treatment Emergent Adverse Events (TEAE). (Secondary), Number, Adverse Events: Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg 3; Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg 5; Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg 13; Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg 8; Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg 5; Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg 7; Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg 5
• 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). (Primary), Mean, Hounsfield Units: Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg 191 +/- 34.6; Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg 230 +/- 40.2; Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg 212 +/- 22.2; Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg 261 +/- 37.7; Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg 246 +/- 36.6; Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg 240 +/- 49.4; Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg 257 +/- 9.5

Adverse events

Time frame: Up to 72 hours post Ioforminal or Iopamidol administration.

Other adverse events by term

• Rubin Sheng, MD, Study director, GE Healthcare