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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: dimethyl fumarate - Reference form; Drug: dimethyl fumarate - Test form

• Registration Number: NCT02171208
• Lead Sponsor: Biogen

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test, Reference, Reference (TRR)	dimethyl fumarate - Test form	Doses will be separated by a washout period
Reference, Test, Reference (RTR)	dimethyl fumarate - Reference form	Doses will be separated by a washout period
Reference, Test, Reference (RTR)	dimethyl fumarate - Test form	Doses will be separated by a washout period
Test, Reference, Reference (TRR)	dimethyl fumarate - Reference form	Doses will be separated by a washout period

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to peak plasma concentration (Tmax)	Up to 48 hours following each dose administration
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Evansville, Indiana, United States