A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
Primary Purpose
Relapsing Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BG00012
BG00012
Sponsored by
About this trial
This is an interventional basic science trial for Relapsing Remitting Multiple Sclerosis
Eligibility Criteria
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.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
240 mg (two 120 mg capsules) twice a day
240 mg (two 120 mg capsules) three times a day
Outcomes
Primary Outcome Measures
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
Secondary Outcome Measures
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00837785
Brief Title
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
Official Title
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2009 (Actual)
Primary Completion Date
October 31, 2009 (Actual)
Study Completion Date
October 31, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
240 mg (two 120 mg capsules) twice a day
Arm Title
2
Arm Type
Experimental
Arm Description
240 mg (two 120 mg capsules) three times a day
Intervention Type
Drug
Intervention Name(s)
BG00012
Intervention Description
240 mg (two 120 mg capsules) orally three times a day
Intervention Type
Drug
Intervention Name(s)
BG00012
Intervention Description
240 mg (two 120 mg capsules) orally twice a day
Primary Outcome Measure Information:
Title
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
Time Frame
24 Hours
Secondary Outcome Measure Information:
Title
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
Time Frame
24 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Berlin
Country
Germany
12. IPD Sharing Statement
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A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
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