[Iodixanol. A new isotonic x-ray contrast medium]

Area of Science:

• Radiology and Imaging
• Pharmacology
• Nephrology

Background:

• Iodinated contrast media are essential for medical imaging.
• Assessing the safety and pharmacokinetic profile of new contrast agents is crucial.
• Iodixanol is a nonionic, dimeric contrast medium.

Purpose of the Study:

• To evaluate the safety, tolerance, and pharmacokinetics of iodixanol (300 mg I/ml) in healthy male volunteers.
• To determine the influence of iodixanol on renal function, hemodynamics, and clinical parameters.
• To compare the renal effects of iodixanol with other nonionic contrast media.

Main Methods:

• Phase I clinical trial involving 40 healthy male volunteers.
• Administration of iodixanol at four different dose levels.
• Monitoring of renal function parameters, hemodynamics, ECG, and clinical-chemical parameters.
• Assessment of adverse events and kidney cortex density via CT-imaging.

Main Results:

• Iodixanol was safe and well-tolerated, with no clinically significant adverse effects on renal function, hemodynamics, or ECG.
• Only three adverse events (sensation of warmth) were possibly related to iodixanol.
• CT-scans showed a dose-related, reversible increase in kidney cortex density.
• No changes in glomerular function were observed; tubular enzyme excretion was minimal compared to other agents.

Conclusions:

• Iodixanol exhibits a favorable safety and tolerance profile in healthy individuals.
• Its pharmacokinetic properties and minimal impact on renal function support its potential use in clinical practice.
• Further clinical trials in patient populations are warranted to confirm safety and efficacy.