Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

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

NCTNCT01004770Other idGE-145-001

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Names hCG (human chorionic gonadotropin), does not test it. It appears in the conditions.

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 50 participants (actual)
Sponsor: GE Healthcare · Industry
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: Oct 2009
Primary completion: Feb 2010
Completion: May 2010
First posted: 30 Oct 2009 (estimated)
Last update posted: 5 Apr 2012 (estimated)
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 1/2
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
NCT01004770
Oct 2009 to May 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

GE-145 (AN113111) InjectionDrug
Visipaque (iodixanol) InjectionDrug

Arms2

Experimental
1 (AH113111 Injection)
Active comparator
2 (Visipaque Injection)
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Primary outcomes5

Outcomes the sponsor listed as primary.

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and up to and including 72 hours post contrast administration

Blood Urea Nitrogen and Creatinine Serum Values

Group	Value (mg/dL)	Spread
GE-145 Injection-300mg of Iodine/mL	12.3	3.2
GE-145 Injection-450mg of Iodine/mL	14.7	3.0
GE-145 Injection-600mg of Iodine/mL	14.5	4.3
GE-145 Injection-900mg of Iodine/mL	12.8	4.5
Visipaque Injection	11.9	4.6

Primary outcomeMean· Baseline and up to and including 8 hours post contrast administation.

Vital Signs (Blood Pressure) Systolic and Diastolic Values

Group	Value (mm Hg)	Spread
GE-145 Injection-300mg of Iodine/mL	113.1	10.87
GE-145 Injection-450mg of Iodine/mL	125.5	13.10
GE-145 Injection-600mg of Iodine/mL	116.3	11.49
GE-145 Injection-900mg of Iodine/mL	114.9	12.98
Visipaque Injection	118.1	12.15

Primary outcomeMean· Baseline and up to and including 8 hours post contrast administration

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

Group	Value (> 10 beats per minute (bpm))	Spread
GE-145 Injection-300mg of Iodine/mL	65.8	8.35
GE-145 Injection-450mg of Iodine/mL	76.0	11.53
GE-145 Injection-600mg of Iodine/mL	77.9	6.23
GE-145 Injection-900mg of Iodine/mL	75.9	15.00
Visipaque Injection	86.1	7.40

Primary outcomeMean· Baseline and up to and including 24 hours post contrast administration

12-Lead Electrocardiogram (ECG) Values

Group	Value (QTcB (msec))	Spread
GE-145 Injection-300mg of Iodine/mL	408.6	24.3
GE-145 Injection-450mg of Iodine/mL	420.2	21.2
GE-145 Injection-600mg of Iodine/mL	425.0	17.9
GE-145 Injection-900mg of Iodine/mL	410.2	20.8
Visipaque Injection	435.6	17.8

Primary outcomeMean· Pre and post contrast administration

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

Group	Value (Hounsfield Units)	Spread
GE-145 Injection-300mg of Iodine/mL	39.8	5.87
GE-145 Injection-450mg of Iodine/mL	44.0	5.83
GE-145 Injection-600mg of Iodine/mL	44.7	4.21
GE-145 Injection-900mg of Iodine/mL	43.9	3.56
Visipaque Injection	44.5	7.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
GE-145 Injection-300mg of Iodine/mLGE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.	–	0 / 10	2 / 10
GE-145 Injection-450mg of Iodine/mLGE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.	–	1 / 10	1 / 10
GE-145 Injection-600mg of Iodine/mLGE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.	–	0 / 10	0 / 10
GE-145 Injection-900mg of Iodine/mLGE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.	–	0 / 10	0 / 10
Visipaque InjectionVisipaque x 320mgI/mL at a dose of 450mgI/kg	–	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 60 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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.

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