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

Biogen

Status and phase

Completed

Phase 1

Conditions

Relapsing Remitting Multiple Sclerosis

Treatments

Drug: BG00012

Study type

Interventional

Funder types

Industry

Identifiers

NCT00837785

109MS101

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 18 to 55 years old, inclusive, at the time of informed consent.
Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
Be ambulatory.

Exclusion criteria

Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
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.
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.
Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.