Conditions: Healthy
Keywords: BG00012 gastrointestinal events flushing events dose titration pre-medication aspirin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 173
Healthy volunteers: yes

Brief summary:
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.

Detailed description:

Arms:
arm 1: Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks. arm 2: Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks. arm 3: Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks. arm 4: Participants received BG00012 for 8 weeks (120 mg once daily \[QD\] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.

Interventions: intervention 1: BG00012 (dimethyl fumarate) intervention 2: BG00012 placebo intervention 3: ASA intervention 4: ASA placebo
Intervention descriptions: intervention 1: Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks. intervention 2: Placebo matching BG00012 intervention 3: 325 mg microcoated aspirin (ASA) intervention 4: Placebo matching aspirin

Protocol document: