Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Abdominal CECT in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 11/30/-0001 |
| Start Date: | July 2012 |
| End Date: | October 2012 |
| Contact: | Kristen Barooshian |
| Email: | Kristen.Barooshian@Quintiles.com |
| Phone: | 919-998-7062 |
A Phase 1/2, Open Label, Randomized Study of Low Concentration Ioforminol Injections for Use in Contrast-Enhanced Abdominal Computed Tomography in Healthy Volunteers
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.
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.
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