HealthyPhase 1NCT01069913
Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
A Phase 1 study testing BG00012 in people with Healthy, run by Biogen.
Trial summary
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BG00012
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2010
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males 18 to 55 years old, inclusive, at the time of informed consent.
- Must weigh between 50 kg and 110 kg, inclusive.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
- All subjects 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.
- Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
- Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).
Who cannot join
- History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- History of severe allergic or anaphylactic reaction.
- History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
- Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
About this study
Official title: A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers
The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.
- Conditions
- Healthy
- Being tested
- BG00012
- Keywords
- Healthy Volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00012Drug
Sequence 1: Oral 240 mg BG00012 Standard Formulation \& Following 7 day washout period, 240 mg BG00012 API.
Sequence 2: 240 mg BG00012 API \& Following 7 day washout period, 240 mg BG00012 Standard Formulation.
| Study group | Role | What they receive |
|---|---|---|
| BG00012 | Active comparator | BG00012 Standard Formulation Receives: Drug: BG00012 |
| BG00012 API | Active comparator | BG00012 API Receives: Drug: BG00012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve
Measured: 4 days post dosing period 2
Secondary outcomes (1)
To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API
Measured: 4 days after dosing period 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionJan 2010
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen Idec Medical Director, Study director, Biogen Idec, Cambridge, MA USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069913
- Sponsor's protocol ID
- 109HV105
- Status last verified
- Feb 2010
- First submitted
- 12 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01069913
- Acronym / sponsor ID
- 109HV105
- Conditions
- Healthy
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Feb 2010 (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 measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BG00012 | Active comparator | Drug: BG00012BG00012 Standard Formulation |
| BG00012 API | Active comparator | Drug: BG00012BG00012 API |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males 18 to 55 years old, inclusive, at the time of informed consent.
- Must weigh between 50 kg and 110 kg, inclusive.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
- All subjects 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.
- Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
Key exclusion criteria (5 listed)
- History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- History of severe allergic or anaphylactic reaction.
- History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
- Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
- Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
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 |
|---|---|---|
| BG00012Sequence 1: Oral 240 mg BG00012 Standard Formulation \& Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API \& Following 7 day washout period, 240 mg BG00012 Standard Formulation. | Drug | BG00012, BG00012 API |
Primary outcome
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve
Time frame: 4 days post dosing period 2
1 secondary outcome
To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API
Time frame: 4 days after dosing period 2
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 17 Feb 2010.
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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.
Biogen Idec Medical Director study director
Biogen Idec, Cambridge, MA USA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG00012 in people with Healthy, run by Biogen.
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 6 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve (time frame: 4 days post dosing period 2). 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 17 Feb 2010; AzTrials last refreshed its copy on 7 Nov 2026.