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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04978298 | Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants | PHASE1 | COMPLETED | 128 | — | — | Jul 19, 2021 | Feb 26, 2023 | Aug 31, 2023 | 1 | United States |
The ratio of Tyramine pressor response (Tyr30) in Period 1 over Tyr30 in Period 3.
| Arm | Type | Description |
|---|---|---|
| Rasagiline group | EXPERIMENTAL | Participants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72. |
| Phenelzine group | EXPERIMENTAL | Participants will receive phenelzine twice daily (BID) for 14 days from Days 59 to 72. |
| Ozanimod Therapeutic group | EXPERIMENTAL | Participants will receive ozanimod QD for 65 days (including the initial 7-day dose escalation) from Days 8 to 72. |
| Ozanimod Supra-therapeutic group | EXPERIMENTAL | Participants will receive ozanimod QD for 65 days (including the initial 10-day dose escalation) from Days 8 to 72. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive matched appropriate placebos from Days 8 to 72. |
| Name | Type | Description |
|---|---|---|
| Placebo | OTHER | Placebo |
| Rasigiline | DRUG | Rasigiline |
| Phenelzine | DRUG | Phenelzine |
| Ozanimod | DRUG | Ozanimod |
Inclusion Criteria: Participants must satisfy the following criteria to be enrolled in the study: 1. Be a male or non-pregnant, non-lactating female, 25 to 55 years of age, inclusive, at the time of signing the informed consent form. 2. Must understand and voluntarily sign an informed consent form...