HealthyPhase 1NCT01924832
BG00012 Regional Absorption Study
A Phase 1 study testing dimethyl fumarate in people with Healthy, run by Biogen at 1 site in United Kingdom.
Trial summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Apr 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
- Healthy males or non-pregnant, non-lactating healthy females.
- Body mass index (BMI) of 18 through 35 kg/m2.
- Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment
Who cannot join
- History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
- Vaccinations within 4 weeks prior to first dose.
- History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
- Conditions
- Healthy
- Being tested
- dimethyl fumarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimethyl fumarateDrug
Also called DMF, Tecfidera, BG00012
tablet
| Study group | Role | What they receive |
|---|---|---|
| BG00012 Part 1 | Experimental | BG00012 120 mg delivered to varying locations of the GI tract Receives: Drug: dimethyl fumarate |
| BG00012 Part 2 | Experimental | BG00012 240 mg delivered to varying locations of the GI tract Receives: Drug: dimethyl fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum observed concentration: Cmax
Measured: Up to week 9
The time to reach maximum observed concentration: Tmax
Measured: Up to week 9
The area under the plasma concentration versus time curve from time zero to 24 hours
Measured: Up to week 9
The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])
Measured: Up to week 9
The area under the plasma concentration versus time curve from time zero to infinity
Measured: Up to week 9
The apparent elimination half-life
Measured: Up to week 9
The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration
Measured: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1
Measured: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2
Measured: Up to week 9
Secondary outcomes (1)
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Up to week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 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
- NCT01924832
- Sponsor's protocol ID
- 109HV111
- Other IDs
- EUDRA CT NO: 2013-002048-96
- Status last verified
- Feb 2015
- First submitted
- 1 Aug 2013
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01924832
- Acronym / sponsor ID
- 109HV111
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Aug 2013 (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 evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00012 Part 1 | Experimental | Drug: dimethyl fumarateBG00012 120 mg delivered to varying locations of the GI tract |
| BG00012 Part 2 | Experimental | Drug: dimethyl fumarateBG00012 240 mg delivered to varying locations of the GI tract |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or non-pregnant, non-lactating healthy females.
- Body mass index (BMI) of 18 through 35 kg/m2.
- Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment
Key exclusion criteria (7 listed)
- History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
- Vaccinations within 4 weeks prior to first dose.
- History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
- History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
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 fumarateAlso: DMF, Tecfidera, BG00012tablet | Drug | BG00012 Part 1, BG00012 Part 2 |
Primary outcome
The maximum observed concentration: Cmax
Time frame: Up to week 9
The time to reach maximum observed concentration: Tmax
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to 24 hours
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])
Time frame: Up to week 9
The area under the plasma concentration versus time curve from time zero to infinity
Time frame: Up to week 9
The apparent elimination half-life
Time frame: Up to week 9
The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration
Time frame: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1
Time frame: Up to week 9
Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2
Time frame: Up to week 9
1 secondary outcome
The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to week 9
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 16 Feb 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
1 site 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 in people with Healthy, run by Biogen at 1 site in United Kingdom.
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 3 inclusion and 7 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The maximum observed concentration: Cmax (time frame: Up to week 9). The study lists 9 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 16 Feb 2015.