Clinical trial NCT01004770: Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: CECT - Contrast-enhanced computed tomography
HCG - Human Chorionic Gonadotropin
HU - Hounsfield Units
Patient Safety
Tolerance
Pharmacokinetic
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Medpace, Inc.
name: i3 Statprobe
First posted: 2009-10-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Blood Urea Nitrogen and Creatinine Serum Values
timeFrame: Baseline and up to and including 72 hours post contrast administration
measure: Vital Signs (Blood Pressure) Systolic and Diastolic Values
timeFrame: Baseline and up to and including 8 hours post contrast administation.
measure: Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values
timeFrame: Baseline and up to and including 8 hours post contrast administration
measure: 12-Lead Electrocardiogram (ECG) Values
timeFrame: Baseline and up to and including 24 hours post contrast administration
measure: Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image
timeFrame: Pre and post contrast administration
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, MD
role: STUDY_DIRECTOR
References: