Clinical trial NCT02171208: A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
timeFrame: Up to 48 hours following each dose administration
measure: Maximum observed concentration (Cmax) of BG00012
timeFrame: Up to 48 hours following each dose administration
Secondary outcomes:
measure: The number of participants with adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to Day 13
measure: Area under the plasma concentration curve from time of dosing to 48 hours
timeFrame: Up to 48 hours following each dose administration
measure: Apparent clearance (CL/F)
timeFrame: Up to 48 hours following each dose administration
measure: Time to peak plasma concentration (Tmax)
timeFrame: Up to 48 hours following each dose administration
measure: Lag time (tlag)
timeFrame: Up to 48 hours following each dose administration
measure: Half-life (t1/2)
timeFrame: Up to 48 hours following each dose administration
measure: Intra-subject coefficient of variation (CV%) of the reference product for area under the plasma concentration curve (AUC) and peak plasma concentration (Cmax)
timeFrame: Up to 48 hours following each dose administration
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Evansville
country: United States
facility: Research Site
state: Indiana
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: