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

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GE Healthcare
• Collaborators: Physician Reference Laboratory; Quintiles, Inc.

Criteria

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.