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Completed

NCT Number: NCT01004770

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

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GE-145 (AN113111) Injection

Drug

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

Visipaque (iodixanol) Injection

Drug

An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Other names: Visipaque, Iodixanol

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Medpace, Inc.
  • i3 Statprobe

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 30, 2009
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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