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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: GE-145 (AN113111) Injection; Drug: Visipaque (iodixanol) Injection

• Registration Number: NCT01004770
• Lead Sponsor: GE Healthcare

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-23
• Study First Submitted QC: 2009-10-29
• Study First Posted: 2009-10-30
• Primary Completion: 2010-02
• Study Completion: 2010-05
• Results First Submitted: 2011-09-14
• Results First Submitted QC: 2012-03-07
• Status Verified: 2012-04
• Results First Posted: 2012-04-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 (AH113111 Injection)	GE-145 (AN113111) Injection	-
2 (Visipaque Injection)	Visipaque (iodixanol) Injection	An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Primary Outcome Measures

Name	Time	Method
Blood Urea Nitrogen and Creatinine Serum Values	Baseline and up to and including 72 hours post contrast administration	Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Vital Signs (Blood Pressure) Systolic and Diastolic Values	Baseline and up to and including 8 hours post contrast administation.	Systolic and Diastolic bolld pressure taken up to and including 8 hours
Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values	Baseline and up to and including 8 hours post contrast administration	Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.
12-Lead Electrocardiogram (ECG) Values	Baseline and up to and including 24 hours post contrast administration	12-Lead ECG values taken up to and including 24 hours
Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image	Pre and post contrast administration	Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States