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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

May 31, 2010

Conditions
Healthy
Interventions
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.

Trial Locations (1)

08540

GE Healthcare, Princeton

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

collaborator

i3 Statprobe

INDUSTRY

lead

GE Healthcare

INDUSTRY