A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Or
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis
What it found
We found no results in the registry or in papers.
This trial finished 17 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
24 Hours
How the body handles the medicine
Other measures (1)
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
24 Hours
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
1. Aged 18 to 55 years old, inclusive, at the time of informed consent. 2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. 3. Be ambulatory.
Exclusion criteria
1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS). 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. Other protocol-defined inclusion/exclusion criteria may apply.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2009
Main results due
Oct 2009
Finished
Oct 2009