The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire \[Norquist 2007\], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
56
Research Site
Saint Paul, Minnesota, United States
• incidence of treatment emergent AEs
Time frame: 11 days
• incidence of serious AEs (SAEs)
Time frame: 11 days
• clinical laboratory assessments:
Time frame: 11 days
• Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime.
Time frame: 11 days
• incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements.
Time frame: 11 days
• Incidence, severity, duration, and characteristics of GI events
Time frame: 11 days
• concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine
Time frame: 11 days
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