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

Information source: GE Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: GE-145 (AN113111) Injection (Drug); Visipaque (iodixanol) Injection (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: GE Healthcare

Official(s) and/or principal investigator(s):
Rubin Sheng, MD, Study Director, Affiliation: GE Healthcare

Summary

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.

Clinical Details

Official title: An Intravenous, Single Dose Safety, Tolerance and Pharmacokinetic Study of GE-145 in Healthy Volunteers Undergoing a Contrast-enhanced Abdominal Computed Tomography (CT) Scan

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome:

Blood Urea Nitrogen and Creatinine Serum Values

Vital Signs (Blood Pressure) Systolic and Diastolic Values

Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values

12-Lead Electrocardiogram (ECG) Values

Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

GE Healthcare, Princeton, New Jersey 08540, United States
Additional Information

Starting date: October 2009
Last updated: April 4, 2012

Page last updated: August 23, 2015

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