Status:
COMPLETED
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
Lead Sponsor:
Biogen
Conditions:
Relapsing Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00837785
Start Date
February 28 2009
End Date
October 31 2009
Last Update
February 15 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Berlin, Germany