Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BG00012 Dose 1
* Drug: BG00012 Dose 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give written informed consent and any authorizations required by local law All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Exclusion Criteria: History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible) History of severe allergic or anaphylactic reactions Known history of or positive test result for Human Immunodeficiency Virus (HIV) Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening. Female subjects who are pregnant or currently breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chinese Subjects - Dose 1 BG00012<br> | Drug: BG00012 Dose 1<br> <br> |
| Experimental: Chinese Subjects - Dose 2 BG00012<br> | Drug: BG00012 Dose 2<br> <br> |
| Experimental: Japanese Subjects - Dose 1 BG00012<br> | Drug: BG00012 Dose 1<br> <br> |
| Experimental: Japanese Subjects - Dose 2 BG00012<br> | Drug: BG00012 Dose 2<br> <br> |
| Experimental: Caucasian Subjects - Dose 1 BG00012<br> | Drug: BG00012 Dose 1<br> <br> |
| Experimental: Caucasian Subjects - Dose 2 BG00012<br> | Drug: BG00012 Dose 2<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of BG00012 |  | First dose to 24 hours | 
| Cmax of BG00012 |  | First dose to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 |