BG00012 Regional Absorption Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-04-30

Brief Summary

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The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract 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

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BG00012 Part 1

BG00012 120 mg delivered to varying locations of the GI tract

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

tablet

BG00012 Part 2

BG00012 240 mg delivered to varying locations of the GI tract

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

tablet

Interventions

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dimethyl fumarate

tablet

Intervention Type DRUG

Other Intervention Names

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DMF Tecfidera BG00012

Eligibility Criteria

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Inclusion Criteria

* Healthy males or non-pregnant, non-lactating healthy females.
* Body mass index (BMI) of 18 through 35 kg/m2.
* Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment

Exclusion Criteria

* History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
* Vaccinations within 4 weeks prior to first dose.
* History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
* History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes