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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: Completed Phase 1 study of Multiple Sclerosis, sponsored by Banner Life Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The symptoms measured are (1) nausea, (2) vomiting, (3) diarrhea, (4) upper abdominal pain, (5) lower abdominal pain, (6) constipation, (7) bloating, and (8) flatulence
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 |
What the finished NCT04022473 record still lists
NCT04022473 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (64% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04022473's enrollment target sits among peer trials
210 76th of 315 higher than 240 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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