A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedStudy Start
First participant enrolled
February 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2009
CompletedFebruary 15, 2018
February 1, 2018
8 months
February 4, 2009
February 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
24 Hours
Secondary Outcomes (1)
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
24 Hours
Study Arms (2)
1
EXPERIMENTAL240 mg (two 120 mg capsules) twice a day
2
EXPERIMENTAL240 mg (two 120 mg capsules) three times a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Research Site
Berlin, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
February 28, 2009
Primary Completion
October 31, 2009
Study Completion
October 31, 2009
Last Updated
February 15, 2018
Record last verified: 2018-02