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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.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00837785
First received: February 4, 2009
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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 Idec:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837785

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

No publications provided

Responsible Party: Biogen Idec Inc, Biogen Idec
ClinicalTrials.gov Identifier: NCT00837785     History of Changes
Other Study ID Numbers: 109MS101
Study First Received: February 4, 2009
Last Updated: January 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014