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

Completed · Phase 1/Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01672996

Run by

GE Healthcare

People needed

66

Starts

2012-07-01

Expected to finish

2012-08-01

Last updated by the study team

2014-05-29

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males or females between 18 and 50 years of age.
• The subject has a maximum abdominal circumference of 120 cm or less.

You may not qualify if…

• 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.

Where it is running

• GE Healthcare — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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