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A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

This study has been completed.
Information provided by:
Biogen Identifier:
First received: February 4, 2009
Last updated: January 27, 2011
Last verified: January 2011
To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: BG00012
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS [ Time Frame: 24 Hours ]

Secondary Outcome Measures:
  • To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 [ Time Frame: 24 Hours ]

Enrollment: 48
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
240 mg (two 120 mg capsules) twice a day
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day
Experimental: 2
240 mg (two 120 mg capsules) three times a day
Drug: BG00012
240 mg (two 120 mg capsules) orally three times a day


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Aged 18 to 55 years old, inclusive, at the time of informed consent.
  2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
  3. Be ambulatory.

Exclusion Criteria:

  1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
  2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.
  3. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.
  4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
  5. Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00837785

Research Site
Berlin, Germany
United Kingdom
Research Site
Edinburgh, United Kingdom
Sponsors and Collaborators
  More Information

Responsible Party: Biogen Idec Inc, Biogen Idec Identifier: NCT00837785     History of Changes
Other Study ID Numbers: 109MS101
Study First Received: February 4, 2009
Last Updated: January 27, 2011

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 28, 2017