BG00012 Regional Absorption Study

Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: dimethyl fumarate

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NJ116JS
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG00012 Part 1; BG00012 120 mg delivered to varying locations of the GI tract	Drug: dimethyl fumarate; tablet; Other Names: BG00012; DMF; Tecfidera
Experimental: BG00012 Part 2; BG00012 240 mg delivered to varying locations of the GI tract	Drug: dimethyl fumarate; tablet; Other Names: BG00012; DMF; Tecfidera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The maximum observed concentration: Cmax	Up to week 9
The time to reach maximum observed concentration: Tmax	Up to week 9
The area under the plasma concentration versus time curve from time zero to 24 hours	Up to week 9
The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])	Up to week 9
The area under the plasma concentration versus time curve from time zero to infinity	Up to week 9
The apparent elimination half-life	Up to week 9
The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration	Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1	Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2	Up to week 9

Secondary Outcome Measures

Outcome Measure	Time Frame
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to week 9

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 1, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 19, 2013

Study Record Updates

• Last Update Posted (Estimate): February 16, 2015
• Last Update Submitted That Met QC Criteria: February 12, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109HV111; EUDRA CT NO: 2013-002048-96