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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 240 mg (two 120 mg capsules) twice a day |
|
| 2 | Experimental | 240 mg (two 120 mg capsules) three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00012 | Drug | 240 mg (two 120 mg capsules) orally three times a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012 | 24 Hours |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | Germany |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| BG00012 |
| Drug |
240 mg (two 120 mg capsules) orally twice a day |
|
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009930 |
| Organic Chemicals |