Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate

A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID

The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.

Key Inclusion Criteria:

• Must give written informed consent and any authorizations required by local law
• Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m^2,inclusive.
• Ability to complete the tolerability scales by accurately using the hand-held subject reporting device
• Subjects of childbearing potential must be willing to practice effective contraception

Key Exclusion Criteria:

• History of clinically significant diseases
• History of severe allergic or anaphylactic reactions
• Intolerance to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.