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

General Electric (GE)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Healthy

Treatments: Drug: Ioforminol 200 mgI/mL; Drug: Ioforminol 160 mgI/mL; Drug: Iopamidol 300 mgI/mL

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01672996

GE-145-004

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

Arm 1 - Ioforminol 160mgI/mL

Experimental group

Description:

Single administration of Ioforminol 160mgI/mL given to the subject.

Treatment:

Drug: Ioforminol 160 mgI/mL

Arm 2 - Ioforminol 200mgI/mL

Experimental group

Description:

Given as a single administration to the subject

Treatment:

Drug: Ioforminol 200 mgI/mL

Arm 3 - Iopamidol 300mgI/mL

Active Comparator group

Description:

Given as a single administration to the subject

Treatment:

Drug: Iopamidol 300 mgI/mL