BG00012 Regional Absorption Study

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01924832

109HV111

EUDRA CT NO: 2013-002048-96

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

BG00012 Part 1

Experimental group

Description:

BG00012 120 mg delivered to varying locations of the GI tract

Treatment:

Drug: dimethyl fumarate

BG00012 Part 2

Experimental group

Description:

BG00012 240 mg delivered to varying locations of the GI tract

Treatment:

Drug: dimethyl fumarate