FTY720: placebo-controlled study of the effect on cardiac rate and rhythm in healthy subjects

J Clin Pharmacol. 2006 Aug;46(8):895-904. doi: 10.1177/0091270006289853.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Arrhythmias, Cardiac / chemically induced
  • Blood Pressure / drug effects
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Electrocardiography, Ambulatory / drug effects
  • Exercise Test
  • Female
  • Fingolimod Hydrochloride
  • Heart Conduction System / drug effects*
  • Heart Rate / drug effects*
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / pharmacology*
  • Male
  • Propylene Glycols / adverse effects
  • Propylene Glycols / pharmacology*
  • Reference Values
  • Sphingosine / adverse effects
  • Sphingosine / analogs & derivatives*
  • Sphingosine / pharmacology

Substances

  • Immunosuppressive Agents
  • Propylene Glycols
  • Fingolimod Hydrochloride
  • Sphingosine