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NCT04978298 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants
A Phase 1 study of Healthy Volunteers, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT04978298 is a Phase 1 study of Healthy Volunteers that has completed, run by Celgene. The registered enrollment target is 128 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04978298, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the United States (US). Period 1 will consist of daily escalating doses of tyramine administered until tyramine pressor response (defined as the tyramine dose required to increase systolic blood pressure by at least 30 mm Hg from the daily defined baseline in 3 consecutive measurements within 4 hours after tyramine dosing) is achieved or Day 7. Participants who achieve tyramine pressor response at tyramine doses \>/= 200mg and \</= 700mg are eligible for continuation into Period 2 and will be randomized accordingly. Depending on the group to which a participant is randomized, participants will receive rasagiline, phenelzine, ozanimod (therapeutic dose), ozanimod (supra-therapeutic dose), or placebo in Period 2. The duration of dosing depends on the group to which a participant is randomized. In Period 3, all participants will undergo a sham tyramine challenge and receive a single dose of tyramine placebo. Participants who do not achieve tyramine pressor response following the sham challenge will continue with the tyramine challenge (ie, tyramine pressor tests) for up to 12 additional days. Participants who receive at least one dose of study drug in Period 2 will participate in a follow-up phase during which 2 follow-up telephone calls will be performed, the last of which will occur approximately 80 to 100 days after the last dose of study drug.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Ozanimod
- DRUG Rasigiline
- DRUG Phenelzine
Study Locations (1)
California
- Local Institution - 001 - Anaheim
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2023-02-26 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04978298
The ClinicalTrials.gov registry entry for NCT04978298 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (73% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04978298 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04978298 about?
NCT04978298 is a clinical study titled "Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants". This is a Phase 1, randomized, double-blind, placebo-controlled, active-controlled, comparator controlled, multi-dose, parallel-group study divided into three treatment periods and a follow-up period with five treatment groups. This study will be conducted at 1 clinical research unit (CRU) in the Un...
What is the current status of trial NCT04978298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2021-07-19. Estimated completion is 2023-02-26.
What conditions does trial NCT04978298 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04978298?
The interventions under investigation include: Placebo (OTHER), Ozanimod (DRUG), Rasigiline (DRUG), Phenelzine (DRUG).
Who is sponsoring clinical trial NCT04978298?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04978298 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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