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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen
• Treatments: Aspirin; Dimethyl Fumarate

Criteria

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.