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Sphingosine 1-phosphate receptor modulator

Phenelzine for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until at least 90 days after last dose of study treatment (except for participants who discontinue from the study during period 1 in which case aes will be recorded from screening until 24 hours after the last dose of tyramine)
Awards & highlights

Study Summary

This trial is designed to study the effect of different doses of tyramine on blood pressure in people who are taking rasagiline, phenelzine, or ozanimod. The trial will consist of three periods: daily escalating doses of tyramine until blood pressure is increased by at least 30 mm Hg (Period 1), rasagiline, phenelzine, or ozanimod at different doses (Period 2), and a final tyramine challenge (Period 3). There is also a follow-up phase during which participants will have two telephone calls.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until at least 90 days after last dose of study treatment (except for participants who discontinue from the study during period 1 in which case aes will be recorded from screening until 24 hours after the last dose of tyramine)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until at least 90 days after last dose of study treatment (except for participants who discontinue from the study during period 1 in which case aes will be recorded from screening until 24 hours after the last dose of tyramine) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tyramine Sensitivity Factor (TSF)
Secondary outcome measures
CC1084037 Pharmacokinetics: AUC0-24
CC1084037 Pharmacokinetics: Cmax
CC1084037 Pharmacokinetics: Cmin
+17 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Rasagiline groupExperimental Treatment2 Interventions
Participants will receive rasagiline once daily (QD) for 14 days from Days 59 to 72.
Group II: Phenelzine groupExperimental Treatment2 Interventions
Participants will receive phenelzine twice daily (BID) for 14 days from Days 59 to 72.
Group III: Ozanimod Therapeutic groupExperimental Treatment2 Interventions
Participants will receive ozanimod QD for 65 days (including the initial 7-day dose escalation) from Days 8 to 72.
Group IV: Ozanimod Supra-therapeutic groupExperimental Treatment2 Interventions
Participants will receive ozanimod QD for 65 days (including the initial 10-day dose escalation) from Days 8 to 72.
Group V: PlaceboPlacebo Group1 Intervention
Participants will receive matched appropriate placebos from Days 8 to 72.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phenelzine
FDA approved
Ozanimod
FDA approved
Rasigiline
2021
Completed Phase 1
~130

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,843 Total Patients Enrolled
Massimo Attanasio, MDStudy DirectorCelgene

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other research has been conducted concerning the effectiveness of Phenelzine?

"Presently, there are 12 ongoing clinical experiments evaluating the efficacy of Phenelzine with 9 taking place during Phase 3. Although a majority of these trials is based in Lviv and California, this medication has been tested at 4156 sites worldwide."

Answered by AI

Who is qualified to participate in this trial?

"To be considered for the trial, potential participants must have healthy subjects and fall in between 25 to 55 years old. A total of 136 candidates are being enrolled into this experiment."

Answered by AI

To what extent can Phenelzine be considered perilous to one's health?

"Our team has assigned a value of 1 to the safety profile of phenelzine, given its status as an early phase trial and lack of clinical data in regards to efficacy."

Answered by AI

Are enrollees still able to join this scientific experiment?

"Affirmative. According to information housed on clinicaltrials.gov, this research is actively recruiting individuals who meet the criteria for participation as of September 27th 2022 - a timeline which began with its original posting date of July 19th 2021. The study's goal is to acquire 136 participants from one medical facility."

Answered by AI

In what instances is Phenelzine typically recommended?

"Phenelzine is frequently prescribed to patients suffering from atypical depressive disorder, as well as those afflicted with active secondary progressive multiple sclerosis (SPMS), carcinoma in situ and mental depression."

Answered by AI

What is the scope of participants in this investigation?

"Affirmative. Clinicaltrials.gov exhibits that this research project, which went live on July 19th 2021, is actively recruiting for 136 volunteers from 1 location. Most recently it was updated on September 27th 2022."

Answered by AI

Are participants of this investigation required to be over 30?

"According to the prerequisites of this clinical trial, those who hope to participate must be between 25 and 55 years old."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Anaheim Clinical Trials
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Anaheim Clinical Trials: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
2021. "Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04978298.
~34 spots leftby Apr 2025
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