drugset / Trial / NCT01004770
Single Dose Safety, Tolerance and Pharmacokinetic Study in Healthy Volunteers Undergoing Contrast-enhanced Abdominal Computed Tomography (CT)
Non-randomizedParallel-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2009-10
- Primary completion
- 2010-02
- Completion
- 2010-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Iodixanol | Diagnostic / imaging agent | 450 mg/kg | — |
| Subject | Ioforminol | Diagnostic / imaging agent | 300 mg/kg | Intravenous |
| Subject | Ioforminol | Diagnostic / imaging agent | 450 mg/kg | Intravenous |
| Subject | Ioforminol | Diagnostic / imaging agent | 600 mg/kg | Intravenous |
| Subject | Ioforminol | Diagnostic / imaging agent | 900 mg/kg | Intravenous |
Indications
No indication recorded.