Relapsing Remitting Multiple Sclerosis
Conditions
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.
Interventions
DRUGBG00012
240 mg (two 120 mg capsules) orally three times a day
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS | 24 Hours |
Secondary
| Measure | Time frame |
|---|---|
| To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 | 24 Hours |
Countries
Germany
Outcome results
None listed