Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

Study Overview
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Brief Summary
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This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Detailed Description
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This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Official Title
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A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give written and informed consent and any authorizations required by local law. Males and females 18 - 55 years old inclusive at time of consent. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible). Known history of or positive test result for Human Immunodeficiency Virus (HIV) History of severe allergic or anaphylactic reactions. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC). Current enrollment in any other drug, biologic, or device study.

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Experimental|Bioequivalence of two drug formulations|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration curve as a measure of PK. |  | Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of AEs in participants as a measure of safety and tolerability. |  | Participants will be followed during the time of study - an estimated four days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioequivalence