Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)

General Electric (GE)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Drug: GE-145 (AN113111) Injection

Drug: Visipaque (iodixanol) Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01004770

GE-145-001

Details and patient eligibility

About

This is a non-randomized dose-escalating study that will evaluate the safety and tolerability of GE-145 at four different dose levels through the assessment of clinical laboratories, vital signs, physical examinations, electrocardiograms (ECGs) and the frequency and intensity of adverse events (AEs). It will characterize the pharmacokinetic properties of GE-145 through the evaluation of serum and urine. It will evaluate the radiographic density in regions of interest (ROI) and the overall diagnostic quality following administration of GE-145.

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females between 18 and 60 years of age.
For women who are either surgically sterile or are postmenopausal, enrollment in the study without a pregnancy test at screening will be allowed. For women of childbearing potential, the results of a serum and urine HCG pregnancy test (with the result known on the day of and before IMP administration) must be negative.
Subjects are able and willing to comply with study procedures and sign an informed consent.

Exclusion criteria

Known history of a reaction to any iodinated-based contrast agent or with multiple allergies (i.e. foods, pets, medications, etc).
Subjects receiving any medication for which the use of an iodinated contrast agent is contraindicated (i.e.. metformin).
Subjects with suspicion or diagnosis of hyperthyroidism.
Women that are breastfeeding at the screening and/or enrolment period.
Usage of any non-FDA-approved pharmaceutical or therapy within 30 days prior to screening or enrolment in another clinical study within 30 days prior to screening.