RATIONALE AND OBJECTIVES: To assess the safety and pharmacokinetics of gadoteridol injection (0.5 M) in 18 healthy male volunteers in a phase I clinical trial. METHODS: Volunteers were assigned to one of six dosing groups: 0.05, 0.1, 0.15, 0.2, 0.25, and 0.3 mmol/kg gadoteridol (0.5 M), in an ascending dose study. Physical examination, vital signs, electrocardiogram, clinical laboratory tests, and serum and urine samples were obtained at selected time points before and after administration of gadoteridol. RESULTS AND CONCLUSIONS: No significant changes in vital signs, physical examination, clinical laboratory values, or electrocardiogram, that were believed by the principal investigator to be related to the administration of the contrast agent, were observed. A single adverse event (transient hive) believed to be related to contrast agent administration was observed in one volunteer. Pharmacokinetic data show that the elimination half-life and the distribution half-life were independent of the dose used. The mean distribution half-life was 0.20 +/- 0.04 hours, the mean elimination half-life was 1.57 +/- 0.08 hours, and greater than 94% of the drug was excreted in the urine in 24 hours.
RCT Entities:
RATIONALE AND OBJECTIVES: To assess the safety and pharmacokinetics of gadoteridol injection (0.5 M) in 18 healthy male volunteers in a phase I clinical trial. METHODS: Volunteers were assigned to one of six dosing groups: 0.05, 0.1, 0.15, 0.2, 0.25, and 0.3 mmol/kg gadoteridol (0.5 M), in an ascending dose study. Physical examination, vital signs, electrocardiogram, clinical laboratory tests, and serum and urine samples were obtained at selected time points before and after administration of gadoteridol. RESULTS AND CONCLUSIONS: No significant changes in vital signs, physical examination, clinical laboratory values, or electrocardiogram, that were believed by the principal investigator to be related to the administration of the contrast agent, were observed. A single adverse event (transient hive) believed to be related to contrast agent administration was observed in one volunteer. Pharmacokinetic data show that the elimination half-life and the distribution half-life were independent of the dose used. The mean distribution half-life was 0.20 +/- 0.04 hours, the mean elimination half-life was 1.57 +/- 0.08 hours, and greater than 94% of the drug was excreted in the urine in 24 hours.
Authors: Hyunki Kim; Karri D Folks; Lingling Guo; Cecil R Stockard; Naomi S Fineberg; William E Grizzle; James F George; Donald J Buchsbaum; Desiree E Morgan; Kurt R Zinn Journal: Mol Imaging Biol Date: 2011-02 Impact factor: 3.488
Authors: Andrea Horváth; Csanad G Varallyay; Daniel Schwartz; Gerda B Toth; Joao P Netto; Ramon Barajas; Péter Várallyay; László Szidonya; Jenny Firkins; Emily Youngers; Rongwei Fu; Prakash Ambady; Péter Bogner; Edward A Neuwelt Journal: Magn Reson Med Date: 2017-12-04 Impact factor: 4.668
Authors: Pavol Szomolanyi; Martin Rohrer; Thomas Frenzel; Iris M Noebauer-Huhmann; Gregor Jost; Jan Endrikat; Siegfried Trattnig; Hubertus Pietsch Journal: Invest Radiol Date: 2019-09 Impact factor: 6.016