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

NCT02171208 | Completed Phase 1

• 1 other identifier: 109HV112
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

Reference, Test, Reference (RTR)

ACTIVE COMPARATOR

Doses will be separated by a washout period

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

Test, Reference, Reference (TRR)

ACTIVE COMPARATOR

Doses will be separated by a washout period

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

Interventions

dimethyl fumarate - Reference form DRUG

single dose 240 mg

Also known as: BG00012 Tecfidera®

Reference, Test, Reference (RTR); Test, Reference, Reference (TRR)

dimethyl fumarate - Test form DRUG

single dose 240 mg

Also known as: BG00012

Reference, Test, Reference (RTR); Test, Reference, Reference (TRR)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Research Site

Daytona Beach, Florida, 32117, United States

Location

Research Site

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

US (2)