A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
NCT ID: NCT00837785
Last Updated: 2018-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-02-28
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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1
240 mg (two 120 mg capsules) twice a day
BG00012
240 mg (two 120 mg capsules) orally twice a day
2
240 mg (two 120 mg capsules) three times a day
BG00012
240 mg (two 120 mg capsules) orally three times a day
Interventions
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BG00012
240 mg (two 120 mg capsules) orally three times a day
BG00012
240 mg (two 120 mg capsules) orally twice a day
Eligibility Criteria
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Inclusion Criteria
2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
3. Be ambulatory.
Exclusion Criteria
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.
18 Years
55 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Locations
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Research Site
Berlin, , Germany
Countries
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Other Identifiers
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109MS101
Identifier Type: -
Identifier Source: org_study_id
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