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

Biogen

Status and phase: Completed; Phase 3

Conditions: Healthy

Treatments: Drug: ASA; Drug: ASA placebo; Drug: BG00012 (dimethyl fumarate); Drug: BG00012 placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568112

109HV321

Details and patient eligibility

About

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.

Enrollment: 173 patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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173 participants in 4 patient groups, including a placebo group

BG00012

Experimental group

Description:

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.

Treatment:

Drug: ASA placebo

Drug: BG00012 (dimethyl fumarate)

Drug: BG00012 placebo

Placebo

Placebo Comparator group

Description:

Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.

Treatment:

Drug: ASA placebo

Drug: BG00012 placebo

BG00012 + ASA

Experimental group

Description:

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.

Treatment:

Drug: BG00012 (dimethyl fumarate)

Drug: BG00012 placebo

Drug: ASA

BG00012 Slow Titration

Experimental group

Description:

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.

Treatment:

Drug: ASA placebo

Drug: BG00012 (dimethyl fumarate)

Drug: BG00012 placebo