NCT01004770

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2009-10-30
• Last updated: 2012-04-05
• Results posted: 2012-04-04

Locations

1 site across 1 country: United States