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CompletedNCT01924832Updated Feb 16, 2015

BG00012 Regional Absorption Study

A Phase 1 interventional study of dimethyl fumarate in Healthy, sponsored by Biogen. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-16.

Sponsored by Biogen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    BG00012 Part 1

    BG00012 120 mg delivered to varying locations of the GI tract

    Drug: dimethyl fumarate

  • Experimental
    BG00012 Part 2

    BG00012 240 mg delivered to varying locations of the GI tract

    Drug: dimethyl fumarate

Interventions

  • Drugdimethyl fumarate

    tablet

    Also known as: DMF, Tecfidera, BG00012

06

What researchers measure

Primary outcomes

  1. The maximum observed concentration: Cmax

    Time frame: Up to week 9

  2. The time to reach maximum observed concentration: Tmax

    Time frame: Up to week 9

  3. The area under the plasma concentration versus time curve from time zero to 24 hours

    Time frame: Up to week 9

  4. The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])

    Time frame: Up to week 9

  5. The area under the plasma concentration versus time curve from time zero to infinity

    Time frame: Up to week 9

  6. The apparent elimination half-life

    Time frame: Up to week 9

  7. The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration

    Time frame: Up to week 9

  8. Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1

    Time frame: Up to week 9

  9. Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2

    Time frame: Up to week 9

Secondary outcomes

  1. The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to week 9

07

Study locations

1 site
  • Research Site
    Nottingham, NJ116JS, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01924832
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Aug 19, 2013
Start date
Aug 2013
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Feb 16, 2015

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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