HealthyPhase 1109HV106NCT01281111
Alternate Dosing Regimens of BG00012 in Healthy Volunteers
A Phase 1 study testing Dimethyl Fumarate (BG00012) and Aspirin in people with Healthy, run by Biogen at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo 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 (BG00012) and Aspirin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2011to 18 Mar 2011
- 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
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Aged 18 to 55 years old, inclusive, at the time of informed consent.
- Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
- Must have a body mass index of 18 to 34 kg/m2, inclusive.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Who cannot join
- History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.
- Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.
- History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers
The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
Read the detailed description
Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire [Norquist 2007], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl Fumarate (BG00012)Drug
AspirinDrug
BG00012 matching placeboDrug
ASA matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| BG00012 plus ASA | Experimental | Not described Receives: Drug: Dimethyl Fumarate (BG00012); Drug: Aspirin |
| BG00012 plus ASA matching placebo | Experimental | Not described Receives: Drug: Dimethyl Fumarate (BG00012); Drug: ASA matching placebo |
| BG00012 Placebo plus ASA | Placebo comparator | Not described Receives: Drug: Aspirin; Drug: BG00012 matching placebo |
| BG00012 Placebo plus ASA matching placebo | Experimental | Not described Receives: Drug: BG00012 matching placebo; Drug: ASA matching placebo |
| BG00012 | Experimental | modified dose regimen Receives: Drug: Dimethyl Fumarate (BG00012) |
What is being measured
The primary outcome is the main question the study is designed to answer.
• incidence of treatment emergent AEs
Measured: 11 days
• incidence of serious AEs (SAEs)
Measured: 11 days
• clinical laboratory assessments:
Measured: 11 days
• Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime.
Measured: 11 days
Secondary outcomes (3)
• incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements.
Measured: 11 days
• Incidence, severity, duration, and characteristics of GI events
Measured: 11 days
• concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start1 Feb 2011
- Primary completion18 Mar 2011
- Study completion18 Mar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281111
- Sponsor's protocol ID
- 109HV106
- Acronym
- 109HV106
- Status last verified
- Aug 2023
- First submitted
- 20 Jan 2011
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheikh SI, Nestorov I, Russell H, O'Gorman J, Huang R, Milne GL, Scannevin RH, Novas M, Dawson KT. Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. Clin Ther. 2013 Oct;35(10):1582-1594.e9. doi: 10.1016/j.clinthera.2013.08.009.
PubMed 24139424
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01281111
- Acronym / sponsor ID
- 109HV106 / 109HV106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 18 Mar 2011 (actual)
- Study completion
- 18 Mar 2011 (actual)
- First posted
- 21 Jan 2011 (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 purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo
Detailed description
Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire [Norquist 2007], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BG00012 plus ASA | Experimental | Drug: Dimethyl Fumarate (BG00012), Drug: Aspirin |
| BG00012 plus ASA matching placebo | Experimental | Drug: Dimethyl Fumarate (BG00012), Drug: ASA matching placebo |
| BG00012 Placebo plus ASA | Placebo comparator | Drug: Aspirin, Drug: BG00012 matching placebo |
| BG00012 Placebo plus ASA matching placebo | Experimental | Drug: BG00012 matching placebo, Drug: ASA matching placebo |
| BG00012 | Experimental | Drug: Dimethyl Fumarate (BG00012)modified dose regimen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Aged 18 to 55 years old, inclusive, at the time of informed consent.
- Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
- Must have a body mass index of 18 to 34 kg/m2, inclusive.
- Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Key exclusion criteria (5 listed)
- History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.
- Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.
- History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
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 (BG00012) | Drug | BG00012, BG00012 plus ASA, BG00012 plus ASA matching placebo |
| Aspirin | Drug | BG00012 Placebo plus ASA, BG00012 plus ASA |
| BG00012 matching placebo | Drug | BG00012 Placebo plus ASA, BG00012 Placebo plus ASA matching placebo |
| ASA matching placebo | Drug | BG00012 Placebo plus ASA matching placebo, BG00012 plus ASA matching placebo |
Primary outcome
• incidence of treatment emergent AEs
Time frame: 11 days
• incidence of serious AEs (SAEs)
Time frame: 11 days
• clinical laboratory assessments:
Time frame: 11 days
• Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime.
Time frame: 11 days
3 secondary outcomes
• incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements.
Time frame: 11 days
• Incidence, severity, duration, and characteristics of GI events
Time frame: 11 days
• concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine
Time frame: 11 days
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 23 Aug 2023.
- Derived from this study: PubMed 24139424Sheikh SI, Nestorov I, Russell H, O'Gorman J, Huang R, Milne GL, Scannevin RH, Novas M, Dawson KT. Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. Clin Ther. 2013 Oct;35(10):1582-1594.e9. doi: 10.1016/j.clinthera.2013.08.009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (BG00012) and Aspirin in people with Healthy, run by Biogen at 1 site 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 5 inclusion and 5 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 23 Aug 2023. 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 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. Some participants in this study may receive a placebo. 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?
• incidence of treatment emergent AEs (time frame: 11 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281111, which also lists 1 linked publication.
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 23 Aug 2023.