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This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.
The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chinese Subjects - Dose 1 BG00012 | Experimental |
| |
| Chinese Subjects - Dose 2 BG00012 | Experimental |
| |
| Japanese Subjects - Dose 1 BG00012 | Experimental |
| |
| Japanese Subjects - Dose 2 BG00012 | Experimental |
| |
| Caucasian Subjects - Dose 1 BG00012 | Experimental |
| |
| Caucasian Subjects - Dose 2 BG00012 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BG00012 Dose 1 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| AUC of BG00012 | First dose to 24 hours | |
| Cmax of BG00012 | First dose to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events, as a measure of safety and tolerability | Subjects will be followed for the duration of the study, an expected 20 days | |
| Number of Serious Adverse Events, as a measure of safety and tolerability | Subjects will be followed for the duration of the study, an expected 20 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Melbourne | Victoria | Australia | |||
| Research Site |
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| BG00012 Dose 2 |
| Drug |
|
| Hong Kong |
| Hong Kong |
| China |