Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Phenelzine · 1 trial · 1 indication
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...
Phenelzine is a small molecule drug being studied in a Phase 1 clinical trial in healthy volunteers. The trial is a drug-drug interaction study of ozanimod with tyramine to evaluate the effect on pressor response. It is not approved for any indication and remains investigational.
Phenelzine is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting a Phase 1 clinical trial of the drug in healthy volunteers in the United States.
Phenelzine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is completed, with 92 participants enrolled.
Phenelzine is associated with one completed Phase 1 clinical trial, NCT03694119, titled "Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response." The trial enrolled 92 healthy volunteers in the United States.
No, Phenelzine is not the same as ozanimod. Phenelzine is the drug being studied in a clinical trial that investigates its interaction with ozanimod and tyramine. The trial evaluates the effect on pressor response in healthy volunteers.