NCT01568112 - Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate | Biotech Hunter

Enrollment

173

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

October 31, 2012

Study Completion Date

October 31, 2012

Conditions

Healthy

Interventions

DRUG

BG00012 (dimethyl fumarate)

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.

DRUG

BG00012 placebo

Placebo matching BG00012

DRUG

ASA

325 mg microcoated aspirin (ASA)

DRUG

ASA placebo

Placebo matching aspirin

Trial Locations (1)

Unknown

Research Site, Saint Paul