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