Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

Study Overview
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Brief Summary
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The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.

Official Title
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A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: BG00012


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males 18 to 55 years old, inclusive, at the time of informed consent. Must weigh between 50 kg and 110 kg, inclusive. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive. 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. Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1. Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator). Exclusion Criteria: 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 reaction. History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.

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

Sexes Eligible for Study
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Male

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BG00012<br>BG00012 Standard Formulation | Drug: BG00012<br>* Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.<br>|
| Active Comparator: BG00012 API<br>BG00012 API | Drug: BG00012<br>* Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve |  | 4 days post dosing period 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API |  | 4 days after dosing period 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy Volunteer