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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BG00012

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.

Group Type EXPERIMENTAL

BG00012 (dimethyl fumarate)

Intervention Type DRUG

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.

BG00012 placebo

Intervention Type DRUG

Placebo matching BG00012

ASA placebo

Intervention Type DRUG

Placebo matching aspirin

Placebo

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

Group Type PLACEBO_COMPARATOR

BG00012 placebo

Intervention Type DRUG

Placebo matching BG00012

ASA placebo

Intervention Type DRUG

Placebo matching aspirin

BG00012 + ASA

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.

Group Type EXPERIMENTAL

BG00012 (dimethyl fumarate)

Intervention Type DRUG

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.

BG00012 placebo

Intervention Type DRUG

Placebo matching BG00012

ASA

Intervention Type DRUG

325 mg microcoated aspirin (ASA)

BG00012 Slow Titration

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.

Group Type EXPERIMENTAL

BG00012 (dimethyl fumarate)

Intervention Type DRUG

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.

BG00012 placebo

Intervention Type DRUG

Placebo matching BG00012

ASA placebo

Intervention Type DRUG

Placebo matching aspirin

Interventions

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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.

Intervention Type DRUG

BG00012 placebo

Placebo matching BG00012

Intervention Type DRUG

ASA

325 mg microcoated aspirin (ASA)

Intervention Type DRUG

ASA placebo

Placebo matching aspirin

Intervention Type DRUG

Other Intervention Names

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BG-12 oral fumarate DMF acetylsalicylic acid aspirin

Eligibility Criteria

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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

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

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes