Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03694119 | Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response | PHASE1 | COMPLETED | 92 | — | — | Jul 24, 2018 | Jan 8, 2019 | Jul 19, 2019 | 1 | United States |
Tyramine sensitivity factor (TSF) is the ratio of Tyr30 in Period 1 over Tyr30 in Period 3. Tyr30 is defined as the tyramine dose required to increase systolic blood pressure (SBP) by at least 30 mm Hg from daily defined baseline in three consecutive measurements within 4 hours after tyramine dosing.
| Arm | Type | Description |
|---|---|---|
| Phenelzine | ACTIVE_COMPARATOR | Following tyramine challenging in Period 1, eligible subjects randomly assigned to Phenelzine arm are receiving Phenelzine placebo BID plus ozanimod placebo QD from Days 11 to 31, then receiving Phenelzine 15mg BID plus ozanimod placebo QD from Days 32 to 38. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| Placebo | PLACEBO_COMPARATOR | Following tyramine challenging in Period 1, eligible subjects randomly assigned to Placebo arm are receiving Phenelzine placebo BID plus ozanimod placebo QD from Days 11 to 38. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| ozanimod | EXPERIMENTAL | Following tyramine challenging in Period 1, eligible subjects randomly assigned to ozanimod arm are receiving Phenelzine placebo BID plus ozanimod 1.84mg QD from Days 11 to 38, including dose escalation days. Subjects receive second tyramine challenge from Day 39 to up to Day 49 |
| Name | Type | Description |
|---|---|---|
| Phenelzine | DRUG | Phenelzine |
| Tyramine | DRUG | Tyramine |
| Phenelzine placebo | DRUG | Phenelzine placebo |
| ozanimod placebo | DRUG | ozanimod placebo |
| ozanimod | DRUG | ozanimod |
Inclusion Criteria: 1. Subject is a man or non-pregnant, non-lactating woman, ages 25 to 55 years, inclusive. 2. Female subjects must meet at least 1 of the following criteria: * Negative serum pregnancy test at Screening and Day -1 (WOCBP only). * Postmenopausal (defined as 2 years after th...