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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
54
ozanimod
Pseudoephedrine
ozanimod placebo
ICON Early Phase Services
San Antonio, Texas, United States
Cardiovascular analysis
Day 30 maximum time-matched change from Day 29 in systolic blood pressure (SBP)
Time frame: Days 29 and 30
Pharmacokinetics- Cmax
Maximum observed plasma concentration within dosing interval on Days 1, 5, 8, and 28 for ozanimod and its metabolites, and on Day 30 for pseudoephedrine.
Time frame: up to 30 days
Pharmacokinetics- Cmin
Minimum observed plasma concentration within the dosing interval
Time frame: up to 30 days
Pharmacokinetics- Tmax
Time to Cmax on Days 1, 5, 8, and 28 for ozanimod, and its metabolites, and on Day 30 for pseudoephedrine.
Time frame: up to 30 days
Pharmacokinetics- AUC0-24
Area under the concentration-time curve from time 0 to 24 hours on Days 1, 5, 8, and 28 for ozanimod, its metabolites, total drug and total active drug, and on Day 30 for pseudoephedrine.
Time frame: up to 30 days
Pharmacokinetics- Ctrough
Pre- dose or trough concentration for ozanimod and its metabolites on Days 26-30
Time frame: up to 30 days
Adverse events (AEs)
Number of participants with adverse events
Time frame: up to 30 days
Pharmacokinetics- % total drug related AUC0-24 for each analyte
% total drug related AUC0-24 for ozanimod and each metabolite
Time frame: up to 30 days
Pharmacokinetics- % total active drug related AUC0-24 for each active analyte
% total active drug related AUC0-24 for ozanimod and each active metabolite
Time frame: up to 30 days
Cardiovascular analysis for DBP
Day 30 maximum time-matched change from Day 29 in diastolic blood pressure (DBP)
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30 maximum time-matched change from Day 29 in heart rate (HR)
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 30, 24-hour average change from Day 29 24-hour average in Blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30, 24-hour average change from Day 29 24-hour average in Heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 29 and Day 30 24-hour average for blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Day 29 and Day 30 24-hour average for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Day 30 time-matched changes from Day 29 for blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Time frame: Days 29 and 30
Cardiovascular analysis for heart rate
Day 30 time-matched changes from Day 29 for heart rate
Time frame: Days 29 and 30
Cardiovascular analysis for blood pressure
Observed blood pressure (systolic blood pressure (SBP) and diastolic blood pressure (DBP))
Time frame: Days 29 and 30
Cardiovascular analysis for Heart Rate
Observed heart rate (HR)
Time frame: Days 29 and 30
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