Phase 2
N=50
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01004770 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Apr 2012
Primary outcome: Primary: Blood Urea Nitrogen and Creatinine Serum Values — 12.3; 14.7; 14.5; 12.8 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GE-145 (AN113111) Injection (Drug); Visipaque (iodixanol) Injection (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Urea Nitrogen and Creatinine Serum Values |
12.3; 14.7; 14.5; 12.8; 11.9; 10.8 | — |
| PRIMARY Vital Signs (Blood Pressure) Systolic and Diastolic Values |
113.1; 125.5; 116.3; 114.9; 118.1; 110.6 | — |
| PRIMARY Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values |
65.8; 76.0; 77.9; 75.9; 86.1; 64.1 | — |
| PRIMARY 12-Lead Electrocardiogram (ECG) Values |
408.6; 420.2; 425.0; 410.2; 435.6; 413.5 | — |
| PRIMARY Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image |
39.8; 44.0; 44.7; 43.9; 44.5; 243.8 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01004770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.