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Rasigiline

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Aug 31, 2023

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

Rasigiline · 1 trial · 1 indication

Phase 1 1
NCT04978298Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult ParticipantsHealthy Volunteers
COMPLETED128 Analytics
PHASE1COMPLETED
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
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Study Endpoints

Primary Endpoints

Tyramine Sensitivity Factor (TSF)
Up to Day 85

The ratio of Tyramine pressor response (Tyr30) in Period 1 over Tyr30 in Period 3.

Secondary Endpoints

Heart Rate (HR)
Up to Day 85
Systolic Blood Pressure (SBP)
Up to Day 85
Diastolic Blood Pressure (DBP)
Up to Day 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rasagiline groupEXPERIMENTALParticipants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72.
Phenelzine groupEXPERIMENTALParticipants will receive phenelzine twice daily (BID) for 14 days from Days 59 to 72.
Ozanimod Therapeutic groupEXPERIMENTALParticipants will receive ozanimod QD for 65 days (including the initial 7-day dose escalation) from Days 8 to 72.
Ozanimod Supra-therapeutic groupEXPERIMENTALParticipants will receive ozanimod QD for 65 days (including the initial 10-day dose escalation) from Days 8 to 72.
PlaceboPLACEBO_COMPARATORParticipants will receive matched appropriate placebos from Days 8 to 72.

Interventions

NameTypeDescription
PlaceboOTHERPlacebo
RasigilineDRUGRasigiline
PhenelzineDRUGPhenelzine
OzanimodDRUGOzanimod
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Eligibility Criteria

Age Range25 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Rasigiline

What is Rasigiline?

Rasigiline is an investigational small molecule being developed by Bristol-Myers Squibb Company (BMY). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, and its therapeutic area is classified as Other.

What is Rasigiline used for?

Rasigiline is being studied for use in healthy volunteers. It has not been approved for any medical condition and is still in early clinical development. The drug is currently in Phase 1 trials, with one completed study involving healthy adult participants.

Who makes Rasigiline?

Rasigiline is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug in healthy volunteers. Rasigiline is currently in Phase 1 development.

What phase is Rasigiline in?

Rasigiline is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not currently in active trials.

What clinical trials is Rasigiline in?

Rasigiline has been studied in one clinical trial, NCT04978298, titled "Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants." This Phase 1, placebo-controlled, double-blind, randomized study enrolled 128 healthy volunteers in the United States and has been completed.