Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rasigiline · 1 trial · 1 indication
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...
Rasigiline is an investigational small molecule developed by Bristol-Myers Squibb Company (ticker: BMY). It is in Phase 1 clinical development. No therapeutic indication has been disclosed for Rasigiline, and its therapeutic area is classified as other. It is not described as approved for any use.
Rasigiline is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. Bristol-Myers Squibb is the sponsor of the clinical work conducted for Rasigiline, including the Phase 1 study listed on ClinicalTrials.gov under the identifier NCT04978298.
Rasigiline is in Phase 1 clinical development. One Phase 1 trial of Rasigiline has been completed, and no active trials are currently listed. Because Rasigiline remains investigational, it is not approved by the FDA for any indication.
Rasigiline has been studied in one completed Phase 1 trial, NCT04978298, titled a study to evaluate the pressor effect of oral tyramine during ozanimod treatment in healthy adult participants. That trial enrolled 128 healthy volunteers in the United States, was randomized, double blind, and placebo controlled, and included participants aged 25 years and older.
Rasigiline is a small molecule, but no molecular target or target class has been disclosed for it. Without a disclosed target, its specific mechanism of action cannot be described. The completed Phase 1 trial of Rasigiline examined the pressor effect of oral tyramine in healthy adult participants.