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FTY720: Placebo-Controlled Study of the Effect on Cardiac Rate and Rhythm in Healthy Subjects

From Exploratory Development, Novartis Pharmaceutical Corporation, East Hanover, New Jersey (Dr Schmouder, Ms Serra, Dr Wang, Dr Kovarik, Ms Bastien); Division of Cardiology, Department of Internal Medicine, University of Virginia, Charlottesville, Virginia (Dr DiMarco); and PPD Development, Austin, Texas (Dr Hunt).

The purpose of this double-blind, placebo-controlled study was to measure the effects of FTY720, a novel immunomodulator, on heart rate and rhythm in healthy volunteers. Subjects (n = 66) were randomized to FTY720 1.25 mg or 5 mg or placebo administered once daily for 7 days. Continuous telemetry revealed an acute, dose-dependent decrease in mean heart rate (10-bpm decrease vs placebo) following the first dose of FTY720, with a nadir generally 4 hours postdose. Although a persistent FTY720-related decrease in heart rate was measured from day 2 to day 7, additional doses of FTY720 after day 2 resulted in no further incremental decreases. Mean PR interval increased by approximately 8 to 10 msec in FTY720-treated subjects on day 1. FTY720 did not increase the QRS or QT interval. These results confirm that the first dose of FTY720 has a mild to moderate negative chronotropic effect.

Key Words: FTY720 • cardiac rate and rhythm • immunomodulators

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