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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
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 -
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Arms & Interventions
Reference, Test, Reference (RTR)
Doses will be separated by a washout period
Intervention: dimethyl fumarate - Reference form (Drug)
Reference, Test, Reference (RTR)
Doses will be separated by a washout period
Intervention: dimethyl fumarate - Test form (Drug)
Test, Reference, Reference (TRR)
Doses will be separated by a washout period
Intervention: dimethyl fumarate - Reference form (Drug)
Test, Reference, Reference (TRR)
Doses will be separated by a washout period
Intervention: dimethyl fumarate - Test form (Drug)
Outcomes
Primary Outcomes
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
Time Frame: Up to 48 hours following each dose administration
Maximum observed concentration (Cmax) of BG00012
Time Frame: Up to 48 hours following each dose administration
Secondary Outcomes
- The number of participants with adverse events (AEs) and serious adverse events (SAEs)(Up to Day 13)
- Apparent clearance (CL/F)(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)
- Area under the plasma concentration curve from time of dosing to 48 hours(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)
- Time to peak plasma concentration (Tmax)(Up to 48 hours following each dose administration)