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Biomedical subjects

M A Lucas

Publications and source records attributed to M A Lucas.

28 records · Page 2Linked to original sources
PubMedDate not supplied

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 examination findings, vital signs, or electrocardiogram results were reported for any of the subjects evaluated. No clinically significant changes in clinical laboratory values were noted by the investigators. Fourteen adverse events considered not serious and considered possibly or definitely related to the drug were reported, three of which required minor 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-weighted images. Changes in signal intensity of cervical lymph nodes were also observed at the higher doses and late postdose imaging times.

Adult↗
PubMedDate not supplied

Safety of gadoteridol injection: U.S. clinical trial experience.

As part of the clinical evaluation of gadoteridol injection, intravenous doses ranging from 0.05 to 0.3 mmol/kg were administered to 1,709 patients and volunteers. Safety monitoring included pre- and postdose physical examinations, vital signs, and clinical laboratory values. Adverse event recording included occurrence, duration, severity, relationship to injection, and clinical importance. No clinically important changes in physical examination results, electrocardiograms, or vital signs were attributed to gadoteridol injection except for one case of hypotension. Four clinically important changes in laboratory values possibly or definitely related to the contrast agent were noted in two patients (0.1%). Adverse events were recorded in 118 subjects (6.9%), including nausea in 24 subjects (1.4%) and taste perversion in 22 subjects (1.3%). All other adverse events occurred with a frequency of less than 1%. Adverse events related to contrast agent administration occurred in 79 subjects (4.6%). Gadoteridol injection demonstrated excellent clinical safety and patient tolerance at various doses and injection rates.

Adult↗