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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.

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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

FieldValue
Enrollment Target 210 participants
Start Date 2019-07-07
Est. Completion 2019-10-19
Phase Phase 1

Sponsor

Banner Life Sciences

3 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.