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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
tablet
Research Site
Nottingham, United Kingdom
The maximum observed concentration: Cmax
Time frame: Up to week 9
The time to reach maximum observed concentration: Tmax
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to 24 hours
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to infinity
Time frame: Up to week 9
The apparent elimination half-life
Time frame: Up to week 9
The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration
Time frame: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1
Time frame: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2
Time frame: Up to week 9
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to week 9
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