A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers

Study Overview
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Brief Summary
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The primary objective of this study is to establish the bioequivalence of the test product (BG00012 [dimethyl fumarate] supplied by Biogen Idec OSD) to the reference product (BG00012 supplied by Vifor SA) by comparison of pharmacokinetic (PK) profiles in healthy volunteers. The secondary objectives of this study are to determine the safety and tolerability of the test product compared to the reference product, to estimate PK parameters of the test product and the reference product, and to estimate the intra-subject coefficient of variation (CV%) of the referenced product for both area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax).

Official Title
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A Randomized, Double-Blind, Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers (Vifor SA and Biogen Idec OSD)

Conditions
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Healthy

Intervention / Treatment
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* Drug: dimethyl fumarate - Reference form
* Drug: dimethyl fumarate - Test form


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: BMI of 19.0 to 30.0 kg/m2, inclusive Subjects of reproductive potential must agree to practice effective contraception from at least 14 days prior to the first dose of study drug through at least 30 days after their last dose of study drug. Key Exclusion Criteria: History of any clinically significant cardiac, endocrine, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator. Treatment with another investigational drug or approved therapy for investigational use within 30 days (or 5 half-lives, whichever is longer) prior to Day -1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reference, Test, Reference (RTR)<br>Doses will be separated by a washout period | Drug: dimethyl fumarate - Reference form<br>* single dose 240 mg<br>* Other names: BG00012 Tecfidera®;Drug: dimethyl fumarate - Test form<br>* single dose 240 mg<br>* Other names: BG00012;|
| Active Comparator: Test, Reference, Reference (TRR)<br>Doses will be separated by a washout period | Drug: dimethyl fumarate - Reference form<br>* single dose 240 mg<br>* Other names: BG00012 Tecfidera®;Drug: dimethyl fumarate - Test form<br>* single dose 240 mg<br>* Other names: BG00012;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012 |  | Up to 48 hours following each dose administration | 
| Maximum observed concentration (Cmax) of BG00012 |  | Up to 48 hours following each dose administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events (AEs) and serious adverse events (SAEs) |  | Up to Day 13 | 
| Area under the plasma concentration curve from time of dosing to 48 hours |  | Up to 48 hours following each dose administration | 
| Apparent clearance (CL/F) |  | Up to 48 hours following each dose administration | 
| Time to peak plasma concentration (Tmax) |  | Up to 48 hours following each dose administration | 
| Lag time (tlag) |  | Up to 48 hours following each dose administration | 
| Half-life (t1/2) |  | Up to 48 hours following each dose administration | 
| Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax) |  | Up to 48 hours following each dose administration |