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

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)

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: dimethyl fumarate - Reference form; Drug: dimethyl fumarate - Test form

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: June 20, 2014
• First Submitted That Met QC Criteria: June 23, 2014
• First Posted (Estimate): June 24, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109HV112