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

NCT01004770 | Completed Phase 1 Results DMC

• 1 other identifier: GE-145-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

CECT - Contrast-enhanced computed tomography; HCG - Human Chorionic Gonadotropin; HU - Hounsfield Units; Patient Safety; Tolerance; Pharmacokinetic

Outcome Measures

Primary Outcomes (5)

• Blood Urea Nitrogen and Creatinine Serum Values

  Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.

  Baseline and up to and including 72 hours post contrast administration

• Vital Signs (Blood Pressure) Systolic and Diastolic Values

  Systolic and Diastolic bolld pressure taken up to and including 8 hours

  Baseline and up to and including 8 hours post contrast administation.

• Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values

  Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.

  Baseline and up to and including 8 hours post contrast administration

• 12-Lead Electrocardiogram (ECG) Values

  12-Lead ECG values taken up to and including 24 hours

  Baseline and up to and including 24 hours post contrast administration

• Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image

  Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase

  Pre and post contrast administration

Study Arms (2)

1 (AH113111 Injection)

EXPERIMENTAL

Drug: GE-145 (AN113111) Injection

2 (Visipaque Injection)

ACTIVE COMPARATOR

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

Drug: Visipaque (iodixanol) Injection

Interventions

GE-145 (AN113111) Injection DRUG

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.

Also known as: AH113111, GE-145

1 (AH113111 Injection)

Visipaque (iodixanol) Injection DRUG

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

Also known as: Visipaque, Iodixanol

2 (Visipaque Injection)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• Medpace, Inc.: collaborator
• i3 Statprobe: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Interventions

5-(formyl-(3-(formyl-(3,5-bis (2,3-dihydroxypropylcarbamoyl)-2,4,6-triiodophenyl) amino)-2-hydroxypropyl)amino)-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide; Injections; iodixanol

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Rubin Sheng, MD
• Organization: GE Healthcare

rubin.sheng@ge.com

1-609-514-6899

Study Officials

• Rubin Sheng, MD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 30, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 5, 2012
• Results First Posted: April 4, 2012

Record last verified: 2012-04

Locations

US (1)