Healthy
Conditions
Keywords
CECT - Contrast-enhanced computed tomography, HCG - Human Chorionic Gonadotropin, HU - Hounsfield Units, Patient Safety, Tolerance, Pharmacokinetic
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.
Interventions
DRUGGE-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.
DRUGVisipaque (iodixanol) Injection
An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg.
Sponsors
Medpace, Inc.
i3 Statprobe
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GE-145 Injection-300mg of Iodine/mL GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose. | 10 |
| GE-145 Injection-450mg of Iodine/mL GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose. | 10 |
| GE-145 Injection-600mg of Iodine/mL GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose. | 10 |
| GE-145 Injection-900mg of Iodine/mL GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose. | 10 |
| Visipaque Injection Visipaque x 320mgI/mL at a dose of 450mgI/kg | 10 |
| Total | 50 |
Baseline characteristics
| Characteristic | GE-145 Injection-450mg of Iodine/mL | GE-145 Injection-600mg of Iodine/mL | GE-145 Injection-900mg of Iodine/mL | GE-145 Injection-300mg of Iodine/mL | Visipaque Injection | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 50 Participants |
| Age Continuous | 27.2 years STANDARD_DEVIATION 11.54 | 30.8 years STANDARD_DEVIATION 11.5 | 27.4 years STANDARD_DEVIATION 10.05 | 26.5 years STANDARD_DEVIATION 3.89 | 31.3 years STANDARD_DEVIATION 11.91 | 28.6 years STANDARD_DEVIATION 10.01 |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 10 participants | 10 participants | 50 participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 3 Participants | 2 Participants | 2 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 1 Participants | 7 Participants | 8 Participants | 8 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 1 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 1 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
12-Lead Electrocardiogram (ECG) Values
12-Lead ECG values taken up to and including 24 hours
Time frame: Baseline and up to and including 24 hours post contrast administration
Population: Per Study Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GE-145 Injection-300mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 20 min post | 413.5 QTcB (msec) | Standard Deviation 18.4 |
| GE-145 Injection-300mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - Baseline | 408.6 QTcB (msec) | Standard Deviation 24.3 |
| GE-145 Injection-300mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 24 h post | 412.6 QTcB (msec) | Standard Deviation 15.4 |
| GE-145 Injection-450mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 24 h post | 411.4 QTcB (msec) | Standard Deviation 21.7 |
| GE-145 Injection-450mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - Baseline | 420.2 QTcB (msec) | Standard Deviation 21.2 |
| GE-145 Injection-450mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 20 min post | 422.9 QTcB (msec) | Standard Deviation 22.1 |
| GE-145 Injection-600mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - Baseline | 425.0 QTcB (msec) | Standard Deviation 17.9 |
| GE-145 Injection-600mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 20 min post | 434.0 QTcB (msec) | Standard Deviation 14.2 |
| GE-145 Injection-600mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 24 h post | 430.5 QTcB (msec) | Standard Deviation 18.8 |
| GE-145 Injection-900mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 20 min post | 418.2 QTcB (msec) | Standard Deviation 22.9 |
| GE-145 Injection-900mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - Baseline | 410.2 QTcB (msec) | Standard Deviation 20.8 |
| GE-145 Injection-900mg of Iodine/mL | 12-Lead Electrocardiogram (ECG) Values | ECG - 24 h post | 401.5 QTcB (msec) | Standard Deviation 22.2 |
| Visipaque Injection | 12-Lead Electrocardiogram (ECG) Values | ECG - Baseline | 435.6 QTcB (msec) | Standard Deviation 17.8 |
| Visipaque Injection | 12-Lead Electrocardiogram (ECG) Values | ECG - 24 h post | 424.4 QTcB (msec) | Standard Deviation 19 |
| Visipaque Injection | 12-Lead Electrocardiogram (ECG) Values | ECG - 20 min post | 418.7 QTcB (msec) | Standard Deviation 24.6 |
Primary
Blood Urea Nitrogen and Creatinine Serum Values
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Time frame: Baseline and up to and including 72 hours post contrast administration
Population: Per Study Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 24 h post | 11.1 mg/dL | Standard Deviation 3 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 72 h post | 0.78 mg/dL | Standard Deviation 0.15 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 48 h post | 11.7 mg/dL | Standard Deviation 3.1 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 48 h post | 0.76 mg/dL | Standard Deviation 0.21 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 24 h post | 0.75 mg/dL | Standard Deviation 0.19 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 8 h post | 10.8 mg/dL | Standard Deviation 3.1 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen (BUN) - Baseline | 12.3 mg/dL | Standard Deviation 3.2 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 8 h post | 0.76 mg/dL | Standard Deviation 0.19 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - Baseline | 0.79 mg/dL | Standard Deviation 0.19 |
| GE-145 Injection-300mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 72 h post | 12.2 mg/dL | Standard Deviation 2.3 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 8 h post | 14.2 mg/dL | Standard Deviation 2.8 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen (BUN) - Baseline | 14.7 mg/dL | Standard Deviation 3 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 24 h post | 14.0 mg/dL | Standard Deviation 2.9 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 48 h post | 14.8 mg/dL | Standard Deviation 2.4 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 72 h post | 14.2 mg/dL | Standard Deviation 2.8 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - Baseline | 0.79 mg/dL | Standard Deviation 0.15 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 8 h post | 0.82 mg/dL | Standard Deviation 0.12 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 24 h post | 0.78 mg/dL | Standard Deviation 0.13 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 48 h post | 0.78 mg/dL | Standard Deviation 0.15 |
| GE-145 Injection-450mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 72 h post | 0.74 mg/dL | Standard Deviation 0.13 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - Baseline | 0.64 mg/dL | Standard Deviation 0.1 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 48 h post | 0.62 mg/dL | Standard Deviation 0.11 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 24 h post | 12.5 mg/dL | Standard Deviation 3.2 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 48 h post | 13.7 mg/dL | Standard Deviation 4.7 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 8 h post | 14.7 mg/dL | Standard Deviation 6.5 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 72 h post | 14.9 mg/dL | Standard Deviation 4.6 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 8 h post | 0.64 mg/dL | Standard Deviation 0.11 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen (BUN) - Baseline | 14.5 mg/dL | Standard Deviation 4.3 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 72 h post | 0.64 mg/dL | Standard Deviation 0.13 |
| GE-145 Injection-600mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 24 h post | 0.61 mg/dL | Standard Deviation 0.1 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 8 h post | 11.8 mg/dL | Standard Deviation 4.7 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 72 h post | 0.82 mg/dL | Standard Deviation 0.2 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen (BUN) - Baseline | 12.8 mg/dL | Standard Deviation 4.5 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 24 h post | 11.5 mg/dL | Standard Deviation 3.3 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - Baseline | 0.87 mg/dL | Standard Deviation 0.2 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 24 h post | 0.76 mg/dL | Standard Deviation 0.16 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 48 h post | 0.88 mg/dL | Standard Deviation 0.23 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 8 h post | 0.83 mg/dL | Standard Deviation 0.19 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 48 h post | 12.4 mg/dL | Standard Deviation 3.8 |
| GE-145 Injection-900mg of Iodine/mL | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 72 h post | 12.5 mg/dL | Standard Deviation 3.7 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 48 h post | 11.3 mg/dL | Standard Deviation 3.4 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 48 h post | 0.81 mg/dL | Standard Deviation 0.17 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 72 h post | 12.5 mg/dL | Standard Deviation 4.2 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - Baseline | 0.81 mg/dL | Standard Deviation 0.15 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 72 h post | 0.85 mg/dL | Standard Deviation 0.14 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 8 h post | 0.79 mg/dL | Standard Deviation 0.14 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Blood Urea Nitrogen (BUN) - Baseline | 11.9 mg/dL | Standard Deviation 4.6 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | Creatinine - 24 h post | 0.78 mg/dL | Standard Deviation 0.16 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 24 h post | 11.2 mg/dL | Standard Deviation 2.1 |
| Visipaque Injection | Blood Urea Nitrogen and Creatinine Serum Values | BUN - 8 h post | 12.4 mg/dL | Standard Deviation 2.5 |
Primary
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
Time frame: Pre and post contrast administration
Population: Per Study Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GE-145 Injection-300mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Post-Contrast | 243.8 Hounsfield Units | Standard Deviation 41.78 |
| GE-145 Injection-300mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Pre-Contrast | 39.8 Hounsfield Units | Standard Deviation 5.87 |
| GE-145 Injection-450mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Post-Contrast | 263.6 Hounsfield Units | Standard Deviation 78.6 |
| GE-145 Injection-450mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Pre-Contrast | 44.0 Hounsfield Units | Standard Deviation 5.83 |
| GE-145 Injection-600mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Pre-Contrast | 44.7 Hounsfield Units | Standard Deviation 4.21 |
| GE-145 Injection-600mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Post-Contrast | 301.6 Hounsfield Units | Standard Deviation 74.96 |
| GE-145 Injection-900mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Pre-Contrast | 43.9 Hounsfield Units | Standard Deviation 3.56 |
| GE-145 Injection-900mg of Iodine/mL | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Post-Contrast | 305.8 Hounsfield Units | Standard Deviation 52.64 |
| Visipaque Injection | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Pre-Contrast | 44.5 Hounsfield Units | Standard Deviation 7.01 |
| Visipaque Injection | Radiographic Density of the Region of Interest (ROI) Between Pre and Post Contrast Image | Abdominal aorta-Post-Contrast | 245.8 Hounsfield Units | Standard Deviation 45.69 |
Primary
Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values
Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.
Time frame: Baseline and up to and including 8 hours post contrast administration
Population: Per Study Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GE-145 Injection-300mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 1 h post | 65.1 > 10 beats per minute (bpm) | Standard Deviation 8.67 |
| GE-145 Injection-300mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - Baseline | 65.8 > 10 beats per minute (bpm) | Standard Deviation 8.35 |
| GE-145 Injection-300mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 8 h post | 69.1 > 10 beats per minute (bpm) | Standard Deviation 11.06 |
| GE-145 Injection-300mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 10 min post | 64.1 > 10 beats per minute (bpm) | Standard Deviation 9.78 |
| GE-145 Injection-300mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 20 min post | 65.0 > 10 beats per minute (bpm) | Standard Deviation 10.85 |
| GE-145 Injection-450mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 1 h post | 73.9 > 10 beats per minute (bpm) | Standard Deviation 8.6 |
| GE-145 Injection-450mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 20 min post | 76.0 > 10 beats per minute (bpm) | Standard Deviation 12.41 |
| GE-145 Injection-450mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 10 min post | 75.7 > 10 beats per minute (bpm) | Standard Deviation 11.36 |
| GE-145 Injection-450mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 8 h post | 71.1 > 10 beats per minute (bpm) | Standard Deviation 15.89 |
| GE-145 Injection-450mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - Baseline | 76.0 > 10 beats per minute (bpm) | Standard Deviation 11.53 |
| GE-145 Injection-600mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 20 min post | 75.4 > 10 beats per minute (bpm) | Standard Deviation 5.1 |
| GE-145 Injection-600mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - Baseline | 77.9 > 10 beats per minute (bpm) | Standard Deviation 6.23 |
| GE-145 Injection-600mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 10 min post | 77.1 > 10 beats per minute (bpm) | Standard Deviation 10.38 |
| GE-145 Injection-600mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 1 h post | 72.5 > 10 beats per minute (bpm) | Standard Deviation 9.89 |
| GE-145 Injection-600mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 8 h post | 75.2 > 10 beats per minute (bpm) | Standard Deviation 9.39 |
| GE-145 Injection-900mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 8 h post | 75.2 > 10 beats per minute (bpm) | Standard Deviation 12.04 |
| GE-145 Injection-900mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - Baseline | 75.9 > 10 beats per minute (bpm) | Standard Deviation 15 |
| GE-145 Injection-900mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 1 h post | 77.3 > 10 beats per minute (bpm) | Standard Deviation 9.87 |
| GE-145 Injection-900mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 20 min post | 75.9 > 10 beats per minute (bpm) | Standard Deviation 9.7 |
| GE-145 Injection-900mg of Iodine/mL | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 10 min post | 78.6 > 10 beats per minute (bpm) | Standard Deviation 10.17 |
| Visipaque Injection | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 20 min post | 87.4 > 10 beats per minute (bpm) | Standard Deviation 8.54 |
| Visipaque Injection | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 1 h post | 78.5 > 10 beats per minute (bpm) | Standard Deviation 10.84 |
| Visipaque Injection | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - Baseline | 86.1 > 10 beats per minute (bpm) | Standard Deviation 7.4 |
| Visipaque Injection | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 8 h post | 79.4 > 10 beats per minute (bpm) | Standard Deviation 13.27 |
| Visipaque Injection | Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values | Heart Rate - 10 min post | 86.7 > 10 beats per minute (bpm) | Standard Deviation 8.74 |
Primary
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic and Diastolic bolld pressure taken up to and including 8 hours
Time frame: Baseline and up to and including 8 hours post contrast administation.
Population: Per Study Protocol
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 20 min post | 114.2 mm Hg | Standard Deviation 8.51 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 8 h post | 70.4 mm Hg | Standard Deviation 8.58 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 1 h post | 110.4 mm Hg | Standard Deviation 9.65 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 1 h post | 67.4 mm Hg | Standard Deviation 10.54 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 20 min post | 69.6 mm Hg | Standard Deviation 8.47 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 10 min post | 110.6 mm Hg | Standard Deviation 6.88 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - Baseline | 113.1 mm Hg | Standard Deviation 10.87 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 10 min post | 69.4 mm Hg | Standard Deviation 9.65 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - Baseline | 71.7 mm Hg | Standard Deviation 9.32 |
| GE-145 Injection-300mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 8 h post | 113.6 mm Hg | Standard Deviation 11.19 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 10 min post | 123.4 mm Hg | Standard Deviation 8.32 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - Baseline | 125.5 mm Hg | Standard Deviation 13.1 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 20 min post | 121.8 mm Hg | Standard Deviation 11.44 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 1 h post | 120.5 mm Hg | Standard Deviation 7.59 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 8 h post | 116.6 mm Hg | Standard Deviation 16.6 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - Baseline | 72.5 mm Hg | Standard Deviation 12.33 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 10 min post | 74.3 mm Hg | Standard Deviation 8.25 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 20 min post | 70.8 mm Hg | Standard Deviation 10.17 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 1 h post | 70.0 mm Hg | Standard Deviation 5.79 |
| GE-145 Injection-450mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 8 h post | 70.1 mm Hg | Standard Deviation 10.96 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - Baseline | 74.3 mm Hg | Standard Deviation 9.03 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 1 h post | 70.4 mm Hg | Standard Deviation 7.63 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 20 min post | 120.4 mm Hg | Standard Deviation 5.78 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 1 h post | 115.7 mm Hg | Standard Deviation 11.13 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 10 min post | 115.3 mm Hg | Standard Deviation 11.73 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 8 h post | 99.0 mm Hg | Standard Deviation 8.76 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 10 min post | 73.3 mm Hg | Standard Deviation 10.52 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - Baseline | 116.3 mm Hg | Standard Deviation 11.49 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 8 h post | 64.5 mm Hg | Standard Deviation 5.32 |
| GE-145 Injection-600mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 20 min post | 75.0 mm Hg | Standard Deviation 7.06 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 10 min post | 112.2 mm Hg | Standard Deviation 13.31 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 8 h post | 69.0 mm Hg | Standard Deviation 5.6 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - Baseline | 114.9 mm Hg | Standard Deviation 12.98 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 20 min post | 112.6 mm Hg | Standard Deviation 10.59 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - Baseline | 69.9 mm Hg | Standard Deviation 12.48 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 20 min post | 71.8 mm Hg | Standard Deviation 10.26 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 1 h post | 72.2 mm Hg | Standard Deviation 7.5 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 10 min post | 70.4 mm Hg | Standard Deviation 11.05 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 1 h post | 112.7 mm Hg | Standard Deviation 10.14 |
| GE-145 Injection-900mg of Iodine/mL | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 8 h post | 110.1 mm Hg | Standard Deviation 10.69 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 1 h post | 115.6 mm Hg | Standard Deviation 9 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 1 h post | 72.2 mm Hg | Standard Deviation 8.63 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 8 h post | 115.3 mm Hg | Standard Deviation 13.94 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - Baseline | 77.2 mm Hg | Standard Deviation 9.52 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 8 h post | 68.8 mm Hg | Standard Deviation 10.96 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 10 min post | 76.0 mm Hg | Standard Deviation 9.83 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - Baseline | 118.1 mm Hg | Standard Deviation 12.15 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Diastolic BP - 20 min post | 77.1 mm Hg | Standard Deviation 7.31 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 20 min post | 120.0 mm Hg | Standard Deviation 4.99 |
| Visipaque Injection | Vital Signs (Blood Pressure) Systolic and Diastolic Values | Systolic BP - 10 min post | 118.0 mm Hg | Standard Deviation 5.35 |