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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1 - Ioforminol 160mgI/mL

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

Group Type EXPERIMENTAL

Ioforminol 160 mgI/mL

Intervention Type DRUG

Given as s single administration to the subject

Arm 2 - Ioforminol 200mgI/mL

Given as a single administration to the subject

Group Type EXPERIMENTAL

Ioforminol 200 mgI/mL

Intervention Type DRUG

Given as a single administration to the subject

Arm 3 - Iopamidol 300mgI/mL

Given as a single administration to the subject

Group Type ACTIVE_COMPARATOR

Iopamidol 300 mgI/mL

Intervention Type DRUG

Given as a single administration to the subject

Interventions

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Ioforminol 160 mgI/mL

Given as s single administration to the subject

Intervention Type DRUG

Ioforminol 200 mgI/mL

Given as a single administration to the subject

Intervention Type DRUG

Iopamidol 300 mgI/mL

Given as a single administration to the subject

Intervention Type DRUG

Other Intervention Names

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Ioforminol Ioforminol Iopamidol Isovue 300 Isovue

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes