HealthyPhase 1NCT02171208
A Healthy Volunteer Study to Establish the Bioequivalence of BG00012 Supplied by 2 Different Commercial Manufacturers
A Phase 1 study testing dimethyl fumarate - Reference form and dimethyl fumarate - Test form in people with Healthy, run by Biogen at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- dimethyl fumarate - Reference form and dimethyl fumarate - Test form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Jul 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Daytona Beach, Florida, 32117
Research Site
Evansville, Indiana, 47710
About this study
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)
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
- Being tested
- dimethyl fumarate - Reference form, dimethyl fumarate - Test form
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarate - Reference formDrug
Also called BG00012 Tecfidera®
single dose 240 mg
dimethyl fumarate - Test formDrug
Also called BG00012
single dose 240 mg
| Study group | Role | What they receive |
|---|---|---|
| Reference, Test, Reference (RTR) | Active comparator | Doses will be separated by a washout period Receives: Drug: dimethyl fumarate - Reference form; Drug: dimethyl fumarate - Test form |
| Test, Reference, Reference (TRR) | Active comparator | Doses will be separated by a washout period Receives: Drug: dimethyl fumarate - Reference form; Drug: dimethyl fumarate - Test form |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012
Measured: Up to 48 hours following each dose administration
Maximum observed concentration (Cmax) of BG00012
Measured: Up to 48 hours following each dose administration
Secondary outcomes (7)
The number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to Day 13
Area under the plasma concentration curve from time of dosing to 48 hours
Measured: Up to 48 hours following each dose administration
Apparent clearance (CL/F)
Measured: Up to 48 hours following each dose administration
Time to peak plasma concentration (Tmax)
Measured: Up to 48 hours following each dose administration
Lag time (tlag)
Measured: Up to 48 hours following each dose administration
Half-life (t1/2)
Measured: 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)
Measured: Up to 48 hours following each dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171208
- Sponsor's protocol ID
- 109HV112
- Status last verified
- Jan 2015
- First submitted
- 20 Jun 2014
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02171208
- Acronym / sponsor ID
- 109HV112
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference, Test, Reference (RTR) | Active comparator | Drug: dimethyl fumarate - Reference form, Drug: dimethyl fumarate - Test formDoses will be separated by a washout period |
| Test, Reference, Reference (TRR) | Active comparator | Drug: dimethyl fumarate - Reference form, Drug: dimethyl fumarate - Test formDoses will be separated by a washout period |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dimethyl fumarate - Reference formAlso: BG00012 Tecfidera®single dose 240 mg | Drug | Reference, Test, Reference (RTR), Test, Reference, Reference (TRR) |
| dimethyl fumarate - Test formAlso: BG00012single dose 240 mg | Drug | Reference, Test, Reference (RTR), Test, Reference, Reference (TRR) |
Primary outcome
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
7 secondary outcomes
The number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to Day 13
Area under the plasma concentration curve from time of dosing to 48 hours
Time frame: Up to 48 hours following each dose administration
Apparent clearance (CL/F)
Time frame: Up to 48 hours following each dose administration
Time to peak plasma concentration (Tmax)
Time frame: Up to 48 hours following each dose administration
Lag time (tlag)
Time frame: Up to 48 hours following each dose administration
Half-life (t1/2)
Time frame: 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)
Time frame: Up to 48 hours following each dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dimethyl fumarate - Reference form and dimethyl fumarate - Test form in people with Healthy, run by Biogen at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the concentration-time curve from time 0 to infinity (AUCinf) of BG00012 (time frame: Up to 48 hours following each dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.