Ozanimod is a novel, selective, oral sphingosine-1-phosphate (1 and 5) receptor 
modulator in development for multiple sclerosis and inflammatory bowel disease. 
This randomized, double-blind, placebo-controlled, positive-controlled, 
parallel-group thorough QT study characterized the effects of ozanimod on 
cardiac repolarization in healthy subjects. Eligible subjects were randomized to 
1 of 2 groups: ozanimod (escalated from 0.25 to 2 mg over 14 days) or placebo 
(for 14 days). A single dose of moxifloxacin 400 mg or placebo was administered 
on days 2 and 17. The primary end point was the time-matched, placebo-corrected, 
baseline-adjusted mean QTcF (ΔΔQTcF). A total of 113/124 (91.1%) subjects 
completed the study. The upper limits of the 2-sided 90% confidence intervals 
for ΔΔQTcF for both ozanimod 1 and 2 mg were below the 10-millisecond regulatory 
threshold. No QTcF >480 milliseconds or postdose change in QTcF of 
>60 milliseconds was observed. There was no evidence of a positive relationship 
between concentrations of ozanimod and its active metabolites and ΔΔQTcF. 
Although ozanimod blunted the observed diurnal increase in heart rate, 
excursions below predose heart rates were no greater than with placebo. Results 
demonstrate that ozanimod does not prolong the QTc interval or cause clinically 
significant bradycardia, supporting ozanimod's evolving favorable cardiac safety 
profile.