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NCT03644576 · ClinicalTrials.gov registry record · Phase 1
Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate
A Phase 1 study of Healthy Volunteers, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT03644576: Completed Phase 1 study of Healthy Volunteers, sponsored by Celgene.
NCT03644576 is a Phase 1 study of Healthy Volunteers that has completed, run by Celgene. The registered enrollment target is 54 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03644576, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects. Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. Approximately sixty eligible subjects will be enrolled and randomized in a 1:1 fashion with 30 subjects in each treatment group. Subjects will receive placebo or ozanimod once daily (QD) for 30 days. On Day 30, a single oral dose of pseudoephedrine (PSE) 60 mg will be co-administered with placebo or ozanimod. Study Population The study will enroll approximately 60 healthy men and non-pregnant, non-lactating women, ages 18 to 55 years, inclusive, with a body weight of at least 110 pounds (50 kg) and body mass index within the range of 18.0 to 30.0 kg/m2, inclusive. Length of Study The study duration is 65 ± 2 days.
Primary Outcome
Day 30 maximum time-matched change from Day 29 in systolic blood pressure (SBP)
Conditions Studied
Interventions
- DRUG ozanimod
- DRUG Pseudoephedrine
- DRUG ozanimod placebo
Study Locations (1)
Texas
- ICON Early Phase Services - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2018-07-11 |
| Est. Completion | 2018-09-12 |
| Phase | Phase 1 |
What the finished NCT03644576 record still lists
NCT03644576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which ozanimod is the first listed.
NCT03644576 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03644576 about?
NCT03644576 is a clinical study titled "Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate". The purpose of this study is to evaluate the effect of ozanimod after repeated dosing on blood pressure and heart rate response to a single-dose administration of pseudoephedrine (PSE) in healthy adult subjects. Study Design This is a Phase 1, randomized, double-blind, placebo-controlled study. App...
What is the current status of trial NCT03644576?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2018-07-11. Estimated completion is 2018-09-12.
What conditions does trial NCT03644576 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03644576?
The interventions under investigation include: ozanimod (DRUG), Pseudoephedrine (DRUG), ozanimod placebo (DRUG).
Who is sponsoring clinical trial NCT03644576?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03644576 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03644576's enrollment target sits among peer trials
54 133rd of 283 higher than 151 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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