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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: GE-145 (AN113111) Injection; Drug: Visipaque (iodixanol) Injection

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Urea Nitrogen and Creatinine Serum Values	Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.	Baseline and up to and including 72 hours post contrast administration
Vital Signs (Blood Pressure) Systolic and Diastolic Values	Systolic and Diastolic bolld pressure taken up to and including 8 hours	Baseline and up to and including 8 hours post contrast administation.
Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values	Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.	Baseline and up to and including 8 hours post contrast administration
12-Lead Electrocardiogram (ECG) Values	12-Lead ECG values taken up to and including 24 hours	Baseline and up to and including 24 hours post contrast administration
Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image	Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase	Pre and post contrast administration

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Medpace, Inc.; i3 Statprobe

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 23, 2009
• First Submitted That Met QC Criteria: October 29, 2009
• First Posted (Estimate): October 30, 2009

Study Record Updates

• Last Update Posted (Estimate): April 5, 2012
• Last Update Submitted That Met QC Criteria: April 4, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Patient Safety; Tolerance; Pharmacokinetic; CECT - Contrast-enhanced computed tomography; HCG - Human Chorionic Gonadotropin; HU - Hounsfield Units
• Other Study ID Numbers: GE-145-001