Overview

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

Status:
Completed

Trial end date:
2010-05-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

GE Healthcare

Collaborators:

i3 Statprobe
Medpace, Inc.