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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRA CT NO: 2013-002048-96 |
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The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BG00012 Part 1 | Experimental | BG00012 120 mg delivered to varying locations of the GI tract |
|
| BG00012 Part 2 | Experimental | BG00012 240 mg delivered to varying locations of the GI tract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dimethyl fumarate | Drug | tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum observed concentration: Cmax | Up to week 9 | |
| The time to reach maximum observed concentration: Tmax | Up to week 9 | |
| The area under the plasma concentration versus time curve from time zero to 24 hours | Up to week 9 | |
| The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF]) | Up to week 9 | |
| The area under the plasma concentration versus time curve from time zero to infinity | Up to week 9 | |
| The apparent elimination half-life | Up to week 9 | |
| The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration | Up to week 9 | |
| Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1 | Up to week 9 | |
| Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2 | Up to week 9 |
| Measure | Description | Time Frame |
|---|---|---|
| The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to week 9 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Nottingham | NJ116JS | United Kingdom |
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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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| D009930 |
| Organic Chemicals |