Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Effect of Ozanimod on Blood Pressure and Heart Rate Response to Pseudoephedrine in Healthy Adult Subjects
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.
n/a
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