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

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ClinicalTrials.gov Identifier: NCT01004770
Recruitment Status : Completed
First Posted : October 30, 2009
Results First Posted : April 4, 2012
Last Update Posted : April 5, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: GE-145 (AN113111) Injection Drug: Visipaque (iodixanol) Injection Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : October 2009
Primary Completion Date : February 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
Drug Information available for: Iodixanol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 (AH113111 Injection) Drug: GE-145 (AN113111) Injection
40 healthy volunteers (10 per treatment group) will receive AH113111 320 mg I/mL at 1 of 4 possible doses (300, 450, 600, or 900 mg I/kg) as a single intravenous (IV) administration.
Other Names:
  • AH113111
  • GE-145
Active Comparator: 2 (Visipaque Injection)
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
Drug: Visipaque (iodixanol) Injection
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
Other Names:
  • Visipaque
  • Iodixanol


Outcome Measures

Primary Outcome Measures :
  1. Blood Urea Nitrogen and Creatinine Serum Values [ Time Frame: Baseline and up to and including 72 hours post contrast administration ]
    Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.

  2. Vital Signs (Blood Pressure) Systolic and Diastolic Values [ Time Frame: Baseline and up to and including 8 hours post contrast administation. ]
    Systolic and Diastolic bolld pressure taken up to and including 8 hours

  3. Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values [ Time Frame: Baseline and up to and including 8 hours post contrast administration ]
    Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.

  4. 12-Lead Electrocardiogram (ECG) Values [ Time Frame: Baseline and up to and including 24 hours post contrast administration ]
    12-Lead ECG values taken up to and including 24 hours

  5. Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image [ Time Frame: Pre and post contrast administration ]
    Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004770


Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
Medpace, Inc.
i3 Statprobe
Investigators
Study Director: Rubin Sheng, MD GE Healthcare
More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01004770     History of Changes
Other Study ID Numbers: GE-145-001
First Posted: October 30, 2009    Key Record Dates
Results First Posted: April 4, 2012
Last Update Posted: April 5, 2012
Last Verified: April 2012

Keywords provided by GE Healthcare:
CECT - Contrast-enhanced computed tomography
HCG - Human Chorionic Gonadotropin
HU - Hounsfield Units
Patient Safety
Tolerance
Pharmacokinetic