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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: dimethyl fumarate - Test form; Drug: dimethyl fumarate - Reference form

Study type: Interventional

Funder types: Industry

Identifiers

NCT02171208

109HV112

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Reference, Test, Reference (RTR)

Active Comparator group

Description:

Doses will be separated by a washout period

Treatment:

Drug: dimethyl fumarate - Reference form

Drug: dimethyl fumarate - Test form

Test, Reference, Reference (TRR)

Active Comparator group

Description:

Doses will be separated by a washout period

Treatment:

Drug: dimethyl fumarate - Reference form

Drug: dimethyl fumarate - Test form