Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Medpace, Inc.
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01004770
First received: October 23, 2009
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Healthy
Drug: GE-145 (AN113111) Injection
Drug: Visipaque (iodixanol) Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

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

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

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

  • 12-Lead Electrocardiogram (ECG) Values [ Time Frame: Baseline and up to and including 24 hours post contrast administration ] [ Designated as safety issue: Yes ]
    12-Lead ECG values taken up to and including 24 hours

  • Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image [ Time Frame: Pre and post contrast administration ] [ Designated as safety issue: No ]
    Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01004770     History of Changes
Other Study ID Numbers: GE-145-001
Study First Received: October 23, 2009
Results First Received: September 14, 2011
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

Additional relevant MeSH terms:
Iodixanol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014