MedTrace Logo

Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers

NCT04022473 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2020-01-18

No results posted yet for this 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

Interventions

DRUG

Bafiertam

Over-encapsulated capsule to mask treatment

DRUG

Tecfidera

Over-encapsulated capsule to mask treatment

Sponsors & Collaborators

  • Banner Life Sciences LLC

    lead INDUSTRY

Principal Investigators

  • Kathleen Doisy, MD · BioPharma Services Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-07
Primary Completion
2019-10-19
Completion
2019-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022473 on ClinicalTrials.gov