Trial Outcomes & Findings for Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT) (NCT NCT01004770)
NCT ID: NCT01004770
Last Updated: 2012-04-05
Results Overview
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Baseline and up to and including 72 hours post contrast administration
Results posted on
2012-04-05
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
Visipaque Injection
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
Baseline characteristics by cohort
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
10 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
50 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
|
Age Continuous
|
26.5 years
STANDARD_DEVIATION 3.89 • n=39 Participants
|
27.2 years
STANDARD_DEVIATION 11.54 • n=41 Participants
|
30.8 years
STANDARD_DEVIATION 11.50 • n=35 Participants
|
27.4 years
STANDARD_DEVIATION 10.05 • n=31 Participants
|
31.3 years
STANDARD_DEVIATION 11.91 • n=146 Participants
|
28.6 years
STANDARD_DEVIATION 10.01 • n=19 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
19 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
31 Participants
n=19 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=39 Participants
|
10 participants
n=41 Participants
|
10 participants
n=35 Participants
|
10 participants
n=31 Participants
|
10 participants
n=146 Participants
|
50 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to and including 72 hours post contrast administrationPopulation: Per Study Protocol
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Outcome measures
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
Blood Urea Nitrogen and Creatinine Serum Values
Blood Urea Nitrogen (BUN) - Baseline
|
12.3 mg/dL
Standard Deviation 3.2
|
14.7 mg/dL
Standard Deviation 3.0
|
14.5 mg/dL
Standard Deviation 4.3
|
12.8 mg/dL
Standard Deviation 4.5
|
11.9 mg/dL
Standard Deviation 4.6
|
|
Blood Urea Nitrogen and Creatinine Serum Values
Creatinine - 8 h post
|
0.76 mg/dL
Standard Deviation 0.19
|
0.82 mg/dL
Standard Deviation 0.12
|
0.64 mg/dL
Standard Deviation 0.11
|
0.83 mg/dL
Standard Deviation 0.19
|
0.79 mg/dL
Standard Deviation 0.14
|
|
Blood Urea Nitrogen and Creatinine Serum Values
Creatinine - 24 h post
|
0.75 mg/dL
Standard Deviation 0.19
|
0.78 mg/dL
Standard Deviation 0.13
|
0.61 mg/dL
Standard Deviation 0.10
|
0.76 mg/dL
Standard Deviation 0.16
|
0.78 mg/dL
Standard Deviation 0.16
|
|
Blood Urea Nitrogen and Creatinine Serum Values
BUN - 8 h post
|
10.8 mg/dL
Standard Deviation 3.1
|
14.2 mg/dL
Standard Deviation 2.8
|
14.7 mg/dL
Standard Deviation 6.5
|
11.8 mg/dL
Standard Deviation 4.7
|
12.4 mg/dL
Standard Deviation 2.5
|
|
Blood Urea Nitrogen and Creatinine Serum Values
BUN - 24 h post
|
11.1 mg/dL
Standard Deviation 3.0
|
14.0 mg/dL
Standard Deviation 2.9
|
12.5 mg/dL
Standard Deviation 3.2
|
11.5 mg/dL
Standard Deviation 3.3
|
11.2 mg/dL
Standard Deviation 2.1
|
|
Blood Urea Nitrogen and Creatinine Serum Values
BUN - 48 h post
|
11.7 mg/dL
Standard Deviation 3.1
|
14.8 mg/dL
Standard Deviation 2.4
|
13.7 mg/dL
Standard Deviation 4.7
|
12.4 mg/dL
Standard Deviation 3.8
|
11.3 mg/dL
Standard Deviation 3.4
|
|
Blood Urea Nitrogen and Creatinine Serum Values
BUN - 72 h post
|
12.2 mg/dL
Standard Deviation 2.3
|
14.2 mg/dL
Standard Deviation 2.8
|
14.9 mg/dL
Standard Deviation 4.6
|
12.5 mg/dL
Standard Deviation 3.7
|
12.5 mg/dL
Standard Deviation 4.2
|
|
Blood Urea Nitrogen and Creatinine Serum Values
Creatinine - Baseline
|
0.79 mg/dL
Standard Deviation 0.19
|
0.79 mg/dL
Standard Deviation 0.15
|
0.64 mg/dL
Standard Deviation 0.10
|
0.87 mg/dL
Standard Deviation 0.20
|
0.81 mg/dL
Standard Deviation 0.15
|
|
Blood Urea Nitrogen and Creatinine Serum Values
Creatinine - 48 h post
|
0.76 mg/dL
Standard Deviation 0.21
|
0.78 mg/dL
Standard Deviation 0.15
|
0.62 mg/dL
Standard Deviation 0.11
|
0.88 mg/dL
Standard Deviation 0.23
|
0.81 mg/dL
Standard Deviation 0.17
|
|
Blood Urea Nitrogen and Creatinine Serum Values
Creatinine - 72 h post
|
0.78 mg/dL
Standard Deviation 0.15
|
0.74 mg/dL
Standard Deviation 0.13
|
0.64 mg/dL
Standard Deviation 0.13
|
0.82 mg/dL
Standard Deviation 0.20
|
0.85 mg/dL
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Baseline and up to and including 8 hours post contrast administation.Population: Per Study Protocol
Systolic and Diastolic bolld pressure taken up to and including 8 hours
Outcome measures
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic BP - Baseline
|
113.1 mm Hg
Standard Deviation 10.87
|
125.5 mm Hg
Standard Deviation 13.10
|
116.3 mm Hg
Standard Deviation 11.49
|
114.9 mm Hg
Standard Deviation 12.98
|
118.1 mm Hg
Standard Deviation 12.15
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic BP - 10 min post
|
110.6 mm Hg
Standard Deviation 6.88
|
123.4 mm Hg
Standard Deviation 8.32
|
115.3 mm Hg
Standard Deviation 11.73
|
112.2 mm Hg
Standard Deviation 13.31
|
118.0 mm Hg
Standard Deviation 5.35
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic BP - 20 min post
|
114.2 mm Hg
Standard Deviation 8.51
|
121.8 mm Hg
Standard Deviation 11.44
|
120.4 mm Hg
Standard Deviation 5.78
|
112.6 mm Hg
Standard Deviation 10.59
|
120.0 mm Hg
Standard Deviation 4.99
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic BP - 1 h post
|
110.4 mm Hg
Standard Deviation 9.65
|
120.5 mm Hg
Standard Deviation 7.59
|
115.7 mm Hg
Standard Deviation 11.13
|
112.7 mm Hg
Standard Deviation 10.14
|
115.6 mm Hg
Standard Deviation 9.00
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Systolic BP - 8 h post
|
113.6 mm Hg
Standard Deviation 11.19
|
116.6 mm Hg
Standard Deviation 16.60
|
99.0 mm Hg
Standard Deviation 8.76
|
110.1 mm Hg
Standard Deviation 10.69
|
115.3 mm Hg
Standard Deviation 13.94
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Diastolic BP - Baseline
|
71.7 mm Hg
Standard Deviation 9.32
|
72.5 mm Hg
Standard Deviation 12.33
|
74.3 mm Hg
Standard Deviation 9.03
|
69.9 mm Hg
Standard Deviation 12.48
|
77.2 mm Hg
Standard Deviation 9.52
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Diastolic BP - 10 min post
|
69.4 mm Hg
Standard Deviation 9.65
|
74.3 mm Hg
Standard Deviation 8.25
|
73.3 mm Hg
Standard Deviation 10.52
|
70.4 mm Hg
Standard Deviation 11.05
|
76.0 mm Hg
Standard Deviation 9.83
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Diastolic BP - 20 min post
|
69.6 mm Hg
Standard Deviation 8.47
|
70.8 mm Hg
Standard Deviation 10.17
|
75.0 mm Hg
Standard Deviation 7.06
|
71.8 mm Hg
Standard Deviation 10.26
|
77.1 mm Hg
Standard Deviation 7.31
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Diastolic BP - 1 h post
|
67.4 mm Hg
Standard Deviation 10.54
|
70.0 mm Hg
Standard Deviation 5.79
|
70.4 mm Hg
Standard Deviation 7.63
|
72.2 mm Hg
Standard Deviation 7.50
|
72.2 mm Hg
Standard Deviation 8.63
|
|
Vital Signs (Blood Pressure) Systolic and Diastolic Values
Diastolic BP - 8 h post
|
70.4 mm Hg
Standard Deviation 8.58
|
70.1 mm Hg
Standard Deviation 10.96
|
64.5 mm Hg
Standard Deviation 5.32
|
69.0 mm Hg
Standard Deviation 5.60
|
68.8 mm Hg
Standard Deviation 10.96
|
PRIMARY outcome
Timeframe: Baseline and up to and including 8 hours post contrast administrationPopulation: Per Study Protocol
Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.
Outcome measures
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
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
|
76.0 > 10 beats per minute (bpm)
Standard Deviation 12.41
|
75.4 > 10 beats per minute (bpm)
Standard Deviation 5.10
|
75.9 > 10 beats per minute (bpm)
Standard Deviation 9.70
|
87.4 > 10 beats per minute (bpm)
Standard Deviation 8.54
|
|
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
|
73.9 > 10 beats per minute (bpm)
Standard Deviation 8.60
|
72.5 > 10 beats per minute (bpm)
Standard Deviation 9.89
|
77.3 > 10 beats per minute (bpm)
Standard Deviation 9.87
|
78.5 > 10 beats per minute (bpm)
Standard Deviation 10.84
|
|
Vital Sign (Heart Rate in Beats Per Minute-(Bpm)) Values
Heart Rate - Baseline
|
65.8 > 10 beats per minute (bpm)
Standard Deviation 8.35
|
76.0 > 10 beats per minute (bpm)
Standard Deviation 11.53
|
77.9 > 10 beats per minute (bpm)
Standard Deviation 6.23
|
75.9 > 10 beats per minute (bpm)
Standard Deviation 15.00
|
86.1 > 10 beats per minute (bpm)
Standard Deviation 7.40
|
|
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
|
75.7 > 10 beats per minute (bpm)
Standard Deviation 11.36
|
77.1 > 10 beats per minute (bpm)
Standard Deviation 10.38
|
78.6 > 10 beats per minute (bpm)
Standard Deviation 10.17
|
86.7 > 10 beats per minute (bpm)
Standard Deviation 8.74
|
|
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
|
71.1 > 10 beats per minute (bpm)
Standard Deviation 15.89
|
75.2 > 10 beats per minute (bpm)
Standard Deviation 9.39
|
75.2 > 10 beats per minute (bpm)
Standard Deviation 12.04
|
79.4 > 10 beats per minute (bpm)
Standard Deviation 13.27
|
PRIMARY outcome
Timeframe: Baseline and up to and including 24 hours post contrast administrationPopulation: Per Study Protocol
12-Lead ECG values taken up to and including 24 hours
Outcome measures
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
12-Lead Electrocardiogram (ECG) Values
ECG - 24 h post
|
412.6 QTcB (msec)
Standard Deviation 15.4
|
411.4 QTcB (msec)
Standard Deviation 21.7
|
430.5 QTcB (msec)
Standard Deviation 18.8
|
401.5 QTcB (msec)
Standard Deviation 22.2
|
424.4 QTcB (msec)
Standard Deviation 19.0
|
|
12-Lead Electrocardiogram (ECG) Values
ECG - Baseline
|
408.6 QTcB (msec)
Standard Deviation 24.3
|
420.2 QTcB (msec)
Standard Deviation 21.2
|
425.0 QTcB (msec)
Standard Deviation 17.9
|
410.2 QTcB (msec)
Standard Deviation 20.8
|
435.6 QTcB (msec)
Standard Deviation 17.8
|
|
12-Lead Electrocardiogram (ECG) Values
ECG - 20 min post
|
413.5 QTcB (msec)
Standard Deviation 18.4
|
422.9 QTcB (msec)
Standard Deviation 22.1
|
434.0 QTcB (msec)
Standard Deviation 14.2
|
418.2 QTcB (msec)
Standard Deviation 22.9
|
418.7 QTcB (msec)
Standard Deviation 24.6
|
PRIMARY outcome
Timeframe: Pre and post contrast administrationPopulation: Per Study Protocol
Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase
Outcome measures
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 Participants
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 Participants
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 Participants
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 Participants
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 Participants
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
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
|
263.6 Hounsfield Units
Standard Deviation 78.60
|
301.6 Hounsfield Units
Standard Deviation 74.96
|
305.8 Hounsfield Units
Standard Deviation 52.64
|
245.8 Hounsfield Units
Standard Deviation 45.69
|
|
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
|
44.0 Hounsfield Units
Standard Deviation 5.83
|
44.7 Hounsfield Units
Standard Deviation 4.21
|
43.9 Hounsfield Units
Standard Deviation 3.56
|
44.5 Hounsfield Units
Standard Deviation 7.01
|
Adverse Events
GE-145 Injection-300mg of Iodine/mL
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
GE-145 Injection-450mg of Iodine/mL
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
GE-145 Injection-600mg of Iodine/mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GE-145 Injection-900mg of Iodine/mL
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Visipaque Injection
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 participants at risk
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 participants at risk
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 participants at risk
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 participants at risk
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 participants at risk
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Radiation Exposure
|
0.00%
0/10 • 7 Day Followup
|
10.0%
1/10 • Number of events 1 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
Other adverse events
| Measure |
GE-145 Injection-300mg of Iodine/mL
n=10 participants at risk
GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-450mg of Iodine/mL
n=10 participants at risk
GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-600mg of Iodine/mL
n=10 participants at risk
GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
|
GE-145 Injection-900mg of Iodine/mL
n=10 participants at risk
GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
|
Visipaque Injection
n=10 participants at risk
Visipaque x 320mgI/mL at a dose of 450mgI/kg
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin
|
20.0%
2/10 • Number of events 3 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/10 • 7 Day Followup
|
10.0%
1/10 • Number of events 3 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
0.00%
0/10 • 7 Day Followup
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place