Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
Status:
Recruiting
Trial end date:
2022-11-08
Target enrollment:
Participant gender:
Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled,
comparator controlled, multi-dose, parallel-group study divided into three treatment periods
and a follow-up period with five treatment groups. This study will be conducted at 1 clinical
research unit (CRU) in the United States (US).
Period 1 will consist of daily escalating doses of tyramine administered until tyramine
pressor response (defined as the tyramine dose required to increase systolic blood pressure
by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4
hours after tyramine dosing) is achieved or Day 7.
Participants who achieve tyramine pressor response at tyramine doses >/= 200mg and Phase:
Phase 1