NCT00837785

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	BG00012	240 mg (two 120 mg capsules) orally three times a day
DRUG	BG00012	240 mg (two 120 mg capsules) orally twice a day

Timeline

• Start date: 2009-02-28
• Primary completion: 2009-10-31
• Completion: 2009-10-31
• First posted: 2009-02-05
• Last updated: 2018-02-15

Locations

1 site across 1 country: Germany