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 ValuesVital 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
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