HealthyPhase 1/2NCT01004770

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

A Phase 1/2 study testing GE-145 (AN113111) Injection and Visipaque (iodixanol) Injection in people with Healthy, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: GE-145 (AN113111) Injection and Visipaque (iodixanol) Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Oct 2009to May 2010
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

GE Healthcare
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: An Intravenous, Single Dose Safety, Tolerance and Pharmacokinetic Study of GE-145 in Healthy Volunteers Undergoing a Contrast-enhanced Abdominal Computed Tomography (CT) Scan

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
Being tested: GE-145 (AN113111) Injection, Visipaque (iodixanol) Injection
Keywords: CECT - Contrast-enhanced computed tomography, HCG - Human Chorionic Gonadotropin, HU - Hounsfield Units, Patient Safety, Tolerance, Pharmacokinetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GE-145 (AN113111) InjectionDrug
Also called AH113111, GE-145
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.
Visipaque (iodixanol) InjectionDrug
Also called Visipaque, Iodixanol
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Study groups in NCT01004770
Study group	Role	What they receive
1 (AH113111 Injection)	Experimental	Not described Receives: 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. Receives: Drug: Visipaque (iodixanol) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Urea Nitrogen and Creatinine Serum Values
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Pre and post contrast administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009May 2010

First posted30 Oct 2009 (estimated)
Study startOct 2009
Primary completionFeb 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01004770
Sponsor's protocol ID: GE-145-001
Status last verified: Apr 2012
First submitted: 23 Oct 2009
Last updated: 5 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Intravenous, Single Dose Safety, Tolerance and Pharmacokinetic Study of GE-145 in Healthy Volunteers Undergoing a Contrast-enhanced Abdominal Computed Tomography (CT) Scan
ClinicalTrials.gov ID: NCT01004770
Acronym / sponsor ID: GE-145-001
Conditions: Healthy
Keywords: CECT - Contrast-enhanced computed tomography, HCG - Human Chorionic Gonadotropin, HU - Hounsfield Units, Patient Safety, Tolerance, Pharmacokinetic
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: Medpace, Inc., i3 Statprobe
Study start: Oct 2009
Primary completion: Feb 2010 (actual)
Study completion: May 2010 (actual)
First posted: 30 Oct 2009 (estimated)
Results: Posted 4 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1 (AH113111 Injection)	Experimental	Drug: GE-145 (AN113111) Injection
2 (Visipaque Injection)	Active comparator	Drug: Visipaque (iodixanol) InjectionAn additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GE-145 (AN113111) InjectionAlso: AH113111, GE-14540 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	1 (AH113111 Injection)
Visipaque (iodixanol) InjectionAlso: Visipaque, IodixanolAn additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.	Drug	2 (Visipaque Injection)

Primary outcome

Blood Urea Nitrogen and Creatinine Serum Values
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre and post contrast administration
Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase

Results and safety

Results posted to the registry on 4 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GE-145 Injection-300mg of Iodine/mL	10	10
GE-145 Injection-450mg of Iodine/mL	10	10
GE-145 Injection-600mg of Iodine/mL	10	10
GE-145 Injection-900mg of Iodine/mL	10	10
Visipaque Injection	10	10

Primary outcome: Blood Urea Nitrogen and Creatinine Serum Values

Time frame: Baseline and up to and including 72 hours post contrast administration. Mean (Standard Deviation). Unit: mg/dL

Measure	GE-145 Injection-300mg of Iodine/mL n = 10	GE-145 Injection-450mg of Iodine/mL n = 10	GE-145 Injection-600mg of Iodine/mL n = 10	GE-145 Injection-900mg of Iodine/mL n = 10	Visipaque Injection n = 10
Blood Urea Nitrogen (BUN) - Baseline	12.3 (3.2)	14.7 (3.0)	14.5 (4.3)	12.8 (4.5)	11.9 (4.6)
BUN - 8 h post	10.8 (3.1)	14.2 (2.8)	14.7 (6.5)	11.8 (4.7)	12.4 (2.5)
BUN - 24 h post	11.1 (3.0)	14.0 (2.9)	12.5 (3.2)	11.5 (3.3)	11.2 (2.1)
BUN - 48 h post	11.7 (3.1)	14.8 (2.4)	13.7 (4.7)	12.4 (3.8)	11.3 (3.4)
BUN - 72 h post	12.2 (2.3)	14.2 (2.8)	14.9 (4.6)	12.5 (3.7)	12.5 (4.2)
Creatinine - Baseline	0.79 (0.19)	0.79 (0.15)	0.64 (0.10)	0.87 (0.20)	0.81 (0.15)
Creatinine - 8 h post	0.76 (0.19)	0.82 (0.12)	0.64 (0.11)	0.83 (0.19)	0.79 (0.14)
Creatinine - 24 h post	0.75 (0.19)	0.78 (0.13)	0.61 (0.10)	0.76 (0.16)	0.78 (0.16)

Population analysed: Per Study Protocol

Primary outcome: Vital Signs (Blood Pressure) Systolic and Diastolic Values

Time frame: Baseline and up to and including 8 hours post contrast administation.. Mean (Standard Deviation). Unit: mm Hg

Measure	GE-145 Injection-300mg of Iodine/mL n = 10	GE-145 Injection-450mg of Iodine/mL n = 10	GE-145 Injection-600mg of Iodine/mL n = 10	GE-145 Injection-900mg of Iodine/mL n = 10	Visipaque Injection n = 10
Systolic BP - Baseline	113.1 (10.87)	125.5 (13.10)	116.3 (11.49)	114.9 (12.98)	118.1 (12.15)
Systolic BP - 10 min post	110.6 (6.88)	123.4 (8.32)	115.3 (11.73)	112.2 (13.31)	118.0 (5.35)
Systolic BP - 20 min post	114.2 (8.51)	121.8 (11.44)	120.4 (5.78)	112.6 (10.59)	120.0 (4.99)
Systolic BP - 1 h post	110.4 (9.65)	120.5 (7.59)	115.7 (11.13)	112.7 (10.14)	115.6 (9.00)
Systolic BP - 8 h post	113.6 (11.19)	116.6 (16.60)	99.0 (8.76)	110.1 (10.69)	115.3 (13.94)
Diastolic BP - Baseline	71.7 (9.32)	72.5 (12.33)	74.3 (9.03)	69.9 (12.48)	77.2 (9.52)
Diastolic BP - 10 min post	69.4 (9.65)	74.3 (8.25)	73.3 (10.52)	70.4 (11.05)	76.0 (9.83)
Diastolic BP - 20 min post	69.6 (8.47)	70.8 (10.17)	75.0 (7.06)	71.8 (10.26)	77.1 (7.31)

Population analysed: Per Study Protocol

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

Time frame: Baseline and up to and including 8 hours post contrast administration. Mean (Standard Deviation). Unit: > 10 beats per minute (bpm)

Measure	GE-145 Injection-300mg of Iodine/mL n = 10	GE-145 Injection-450mg of Iodine/mL n = 10	GE-145 Injection-600mg of Iodine/mL n = 10	GE-145 Injection-900mg of Iodine/mL n = 10	Visipaque Injection n = 10
Heart Rate - Baseline	65.8 (8.35)	76.0 (11.53)	77.9 (6.23)	75.9 (15.00)	86.1 (7.40)
Heart Rate - 10 min post	64.1 (9.78)	75.7 (11.36)	77.1 (10.38)	78.6 (10.17)	86.7 (8.74)
Heart Rate - 20 min post	65.0 (10.85)	76.0 (12.41)	75.4 (5.10)	75.9 (9.70)	87.4 (8.54)
Heart Rate - 1 h post	65.1 (8.67)	73.9 (8.60)	72.5 (9.89)	77.3 (9.87)	78.5 (10.84)
Heart Rate - 8 h post	69.1 (11.06)	71.1 (15.89)	75.2 (9.39)	75.2 (12.04)	79.4 (13.27)

Population analysed: Per Study Protocol

Primary outcome: 12-Lead Electrocardiogram (ECG) Values

Time frame: Baseline and up to and including 24 hours post contrast administration. Mean (Standard Deviation). Unit: QTcB (msec)

Measure	GE-145 Injection-300mg of Iodine/mL n = 10	GE-145 Injection-450mg of Iodine/mL n = 10	GE-145 Injection-600mg of Iodine/mL n = 10	GE-145 Injection-900mg of Iodine/mL n = 10	Visipaque Injection n = 10
ECG - Baseline	408.6 (24.3)	420.2 (21.2)	425.0 (17.9)	410.2 (20.8)	435.6 (17.8)
ECG - 20 min post	413.5 (18.4)	422.9 (22.1)	434.0 (14.2)	418.2 (22.9)	418.7 (24.6)
ECG - 24 h post	412.6 (15.4)	411.4 (21.7)	430.5 (18.8)	401.5 (22.2)	424.4 (19.0)

Population analysed: Per Study Protocol

Adverse events

Time frame: 7 Day Followup. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GE-145 Injection-300mg of Iodine/mL	0 of 10 (0%)	2 of 10 (20%)	Not reported
GE-145 Injection-450mg of Iodine/mL	1 of 10 (10%)	1 of 10 (10%)	Not reported
GE-145 Injection-600mg of Iodine/mL	0 of 10 (0%)	0 of 10 (0%)	Not reported
GE-145 Injection-900mg of Iodine/mL	0 of 10 (0%)	0 of 10 (0%)	Not reported
Visipaque Injection	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rubin Sheng, MD study director

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GE-145 (AN113111) Injection and Visipaque (iodixanol) Injection in people with Healthy, run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Urea Nitrogen and Creatinine Serum Values (time frame: Baseline and up to and including 72 hours post contrast administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01004770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2012.