A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
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
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of
monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part
1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
The secondary objective of this study is to evaluate the safety and tolerability profile
following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying
regions within the GI tract in healthy volunteers.
Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers
The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl
fumarate) its main bioactive metabolite, is capable of entering the central nervous system in
SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the
amount of study drug in blood) will be tested to compare with PK samples, the amount of study
drug, in spinal fluid (CSF).
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