PHASE-I CLINICAL-EVALUATION OF A NEW IRON-OXIDE MR CONTRAST AGENT

The safety and magnetic resonance (MR) imaging potential of BMS 180549 , a new superparamagnetic iron oxide contrast agent, were evaluated in a phase I, open-label, placebo-controlled study involving 41 healthy subjects. No clinically significant postdose Changes in physical exami nation findings, vital signs, or electrocardiogram results were report ed for any of the subjects evaluated. No clinically significant change s in clinical laboratory values were noted by the investigators. Fourt een adverse events considered not serious and considered possibly or d efinitely related to the drug were reported, three of which required m inor treatment. Relaxation time measurements in plasma samples showed a strong, dose-dependent, and persistent decrease in T1 and T2 values. Significant changes in MR signal intensity of the blood pool and well -perfused organs (liver and spleen) were noted on both T1- and T2-weig hted images. Changes in signal intensity of cervical lymph nodes were also observed at the higher doses and late postdose imaging times.