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

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ClinicalTrials.gov Identifier: NCT00837785
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : February 15, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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 or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Drug: BG00012 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : February 28, 2009
Actual Primary Completion Date : October 31, 2009
Actual Study Completion Date : October 31, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 [ Time Frame: 24 Hours ]


Information from the National Library of Medicine

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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00837785


Locations
Germany
Research Site
Berlin, Germany
Sponsors and Collaborators
Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT00837785     History of Changes
Other Study ID Numbers: 109MS101
First Posted: February 5, 2009    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Sclerosis
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