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CompletedNCT00837785Updated Feb 15, 2018

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

A Phase 1 interventional study of BG00012 and BG00012 in Relapsing Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 1 site in Germany. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2018-02-15.

Sponsored by Biogen · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Relapsing Remitting Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 48 is close to the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

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
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

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.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    1

    240 mg (two 120 mg capsules) twice a day

    Drug: BG00012

  • Experimental
    2

    240 mg (two 120 mg capsules) three times a day

    Drug: BG00012

Interventions

  • DrugBG00012

    240 mg (two 120 mg capsules) orally three times a day

  • DrugBG00012

    240 mg (two 120 mg capsules) orally twice a day

06

What researchers measure

Primary outcomes

  1. To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS

    Time frame: 24 Hours

Secondary outcomes

  1. To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012

    Time frame: 24 Hours

07

Study locations

1 site
  • Research Site
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00837785
Lead sponsor
Biogen
Responsible party
Sponsor
First posted
Feb 5, 2009
Start date
Feb 28, 2009
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009
Last update
Feb 15, 2018

Oversight

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

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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