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GE-145 · 2 trials · 4 indications
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
Blood Urea Nitrogen and Creatinine serum value results taken up to and including 72 hours.
Systolic and Diastolic bolld pressure taken up to and including 8 hours
Heart Rate (beats per minute-(bpm)) taken up to and including 8 hours.
12-Lead ECG values taken up to and including 24 hours
Radiographic Density differences of the abdominal aorta, pre and post contrast on the Arterial Phase
| Arm | Type | Description |
|---|---|---|
| GE 145 320mg I/ml injection | EXPERIMENTAL | - |
| Iopamidol 370mg I/ml injection | ACTIVE_COMPARATOR | - |
| 1 (AH113111 Injection) | EXPERIMENTAL | - |
| 2 (Visipaque Injection) | ACTIVE_COMPARATOR | An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg. |
| Name | Type | Description |
|---|---|---|
| GE-145 | DRUG | GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration. |
| 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. |
| Visipaque (iodixanol) Injection | DRUG | An additional 10 subjects will receive Visipaque (iodixanol) 320 mg I/mL) at a dose of 450 mg/kg. |
Inclusion Criteria: * Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI. * The subject has at least one of the following comorbidities: * 1\) Chronic renal insufficiency, (eGFR \<60 but 15 mL/min/1.73 m2 accor...
GE-145 is an investigational small molecule being studied for use in cardiovascular imaging. It is being evaluated as a contrast agent for computed tomography (CT) and coronary procedures, including in patients with chronic renal insufficiency, diabetes mellitus, and congestive heart failure.
GE-145 is a contrast agent used in imaging procedures. It is designed to provide contrast enhancement during computed tomography (CT) and coronary angiography, allowing better visualization of blood vessels and tissues. Its mechanism involves iodine-based contrast properties.
GE-145 is being developed by GE HealthCare Technologies Inc. (ticker: GEHC). The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational contrast agent.
GE-145 is in Phase 2 clinical development. A Phase 2 study (NCT01252810) has been completed, evaluating the safety of GE-145 320 mg I/mL injection compared to iopamidol 370 mg I/mL in elderly subjects undergoing coronary procedures.
GE-145 has been studied in two completed trials. NCT01004770 was a Phase 1 study in healthy volunteers undergoing contrast-enhanced abdominal CT. NCT01252810 was a Phase 2 study in elderly subjects with chronic renal insufficiency, diabetes mellitus, or congestive heart failure undergoing coronary procedures.
No, GE-145 is not the same as iopamidol. In a Phase 2 clinical trial, GE-145 320 mg I/mL was compared against iopamidol 370 mg I/mL as an active control. GE-145 is a distinct investigational contrast agent being developed by GE HealthCare.