Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate
Status:
Completed
Trial end date:
2018-09-12
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on
blood pressure and heart rate response to a single-dose administration of pseudoephedrine
(PSE) in healthy adult subjects.
Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study.
Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with
30 subjects in each treatment group.
Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single
oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod.
Study Population The study will enroll approximately 60 healthy men and non-pregnant,
non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110
pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive.
Length of Study The study duration is 65 ± 2 days.