NCT04022473

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

A Randomized, Double-Blind Study to Compare Gastrointestinal Tolerability Following Oral Administration of Bafiertam™ (Monomethyl Fumarate) or Tecfidera® (Dimethyl Fumarate) to Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Banner Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Subjects randomized (1:1) to either Bafiertam (monomethyl fumarate) or Tecfidera (dimethyl fumarate) will enter a double-blind titration period where they will receive either Bafiertam 95 mg twice daily (BID) or Tecfidera 120 mg BID for 7 days. Following the titration period, they will enter a maintenance period in which they will receive Bafiertam 190 mg BID or Tecfidera 240 mg BID for 4 weeks.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Bafiertam	Over-encapsulated capsule to mask treatment
DRUG	Tecfidera	Over-encapsulated capsule to mask treatment

Timeline

• Start date: 2019-07-07
• Primary completion: 2019-10-19
• Completion: 2019-10-19
• First posted: 2019-07-17
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study