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OBJECTIVE Moxifloxacin is a fluoroquinolone with a broad spectrum of antibacterial activity.The aim of this study was to investigate the cardiovascular effects of moxifloxacin,administered to conscious,jacketed cynomolgus monkeys as single oral doses.This was a validation study performed to assess the new DSI Jacketed External Telemetry(JET) system recently installed at CDSER.METHODS There were 6 animals(3 males and 3 females) in two groups.Animals of the same gender were group-housed in the same cage.Animals received 4 doses of vehicle control(3 fe-males) or vehicle control followed by moxifloxacin(3 males) with single ascending doses at 15,45 and 135 mg·kg-1.All animals had at least 3 to 4 dose-free days between each dose level.The JET system(Data Science International,US),including two receivers and 6 devices,was used for continuous ECG data and body temperature(surface) collection for approximately 1 h before,until 24 h after each dose.RESULTS Administration of moxifloxacin to group-housed conscious male primates was associated with a dose-dependent prolongation of QTc interval(increase of 9 and 16% vs timematched vehicle data after 45 and 135 mg·kg-1,respectively).In female monkeys,administered multiple doses of vehicle,QTc was comparable across consecutive dosing days.The results demonstrate the usefulness of the JET system in conscious monkeys for evaluating the cardiovascular effects of drugs under normal physiological conditions.
OBJECTIVE Moxifloxacin is a fluoroquinolone with a broad spectrum of antibacterial activity. The aim of this study was to investigate the cardiovascular effects of moxifloxacin, administered to conscious, jacketed cynomolgus monkeys as single oral doses. This was a validation study performed to assess the new DSI Identities of the same gender were group-housed in the same cage. Animal sized 4 vehicles of vehicle control (JET) system was installed in CDSER.METHODS There were 6 animals (3 males and 3 females) in two groups. 3 fe-males) or vehicle control followed by moxifloxacin (3 males) with single ascending doses at 15, 45 and 135 mg · kg -1. All animals had at least 3 to 4 dose-free days between each dose level. The JET system (Data Science International, US), including two receivers and 6 devices, was used for continuous ECG data and body temperature (surface) collection for approximately 1 h before, until after 24 h after each dose.RESULTS Administration of moxifloxacin to gro up-housed conscious male primates was associated with a dose-dependent prolongation of QTc interval (increase of 9 and 16% vs time-matched vehicle data after 45 and 135 mg · kg -1, respectively) , QTc was comparable across consecutive dosing days. The results demonstrate the usefulness of the JET system in conscious monkeys for evaluating the cardiovascular effects of drugs under normal physiological conditions.