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NCT04022473 · ClinicalTrials.gov registry record · Phase 1
Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers
A Phase 1 study of Multiple Sclerosis, sponsored by Banner Life Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT04022473 is a Phase 1 study of Multiple Sclerosis that has completed, run by Banner Life Sciences. The registered enrollment target is 210 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04022473, a Phase 1 study of Multiple Sclerosis, has completed, sponsored by Banner Life Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate). Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfidera® when administered orally following bioequivalent dose regimens in healthy subjects.
Conditions Studied
Interventions
- DRUG Bafiertam
- DRUG Tecfidera
Study Locations (1)
Missouri
- BioPharma Services, Inc. - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2019-07-07 |
| Est. Completion | 2019-10-19 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04022473
The ClinicalTrials.gov registry entry for NCT04022473 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (64% lower). The listed sponsor is Banner Life Sciences, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Bafiertam is the first listed.
NCT04022473 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT04022473 about?
NCT04022473 is a clinical study titled "Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers". The primary objective of the study is to compare in healthy subjects, the GI tolerability of bioequivalent doses of Bafiertam™(monomethyl fumarate) and its pro-drug Tecfidera® (dimethyl fumarate). Secondary objective of this study is to compare the safety and tolerability of Bafiertam™ and Tecfider...
What is the current status of trial NCT04022473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2019-07-07. Estimated completion is 2019-10-19.
What conditions does trial NCT04022473 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04022473?
The interventions under investigation include: Bafiertam (DRUG), Tecfidera (DRUG).
Who is sponsoring clinical trial NCT04022473?
This trial is sponsored by Banner Life Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04022473 being conducted?
This trial has 1 study location across Missouri. 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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