HealthyPhase 1109HV108NCT01453426
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
A Phase 1 study testing BG00012 Dose 1 and BG00012 Dose 2 in people with Healthy, run by Biogen at 2 sites in 2 countries.
Trial summary
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian 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?
- BG00012 Dose 1 and BG00012 Dose 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to Apr 2012
- 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
- Must give written informed consent and any authorizations required by local law
- 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.
Who cannot join
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- 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 reactions
- Known history of or positive test result for Human Immunodeficiency Virus (HIV)
- Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
- Female subjects who are pregnant or currently breastfeeding
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
Read the detailed description
The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.
The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.
- Conditions
- Healthy
- Being tested
- BG00012 Dose 1, BG00012 Dose 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG00012 Dose 1Drug
BG00012 Dose 2Drug
| Study group | Role | What they receive |
|---|---|---|
| Chinese Subjects - Dose 1 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 1 |
| Chinese Subjects - Dose 2 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 2 |
| Japanese Subjects - Dose 1 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 1 |
| Japanese Subjects - Dose 2 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 2 |
| Caucasian Subjects - Dose 1 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 1 |
| Caucasian Subjects - Dose 2 BG00012 | Experimental | Not described Receives: Drug: BG00012 Dose 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of BG00012
Measured: First dose to 24 hours
Cmax of BG00012
Measured: First dose to 24 hours
Secondary outcomes (2)
Number of Adverse Events, as a measure of safety and tolerability
Measured: Subjects will be followed for the duration of the study, an expected 20 days
Number of Serious Adverse Events, as a measure of safety and tolerability
Measured: Subjects will be followed for the duration of the study, an expected 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012
- Study completionApr 2012
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453426
- Sponsor's protocol ID
- 109HV108
- Acronym
- 109HV108
- Status last verified
- May 2012
- First submitted
- 13 Oct 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01453426
- Acronym / sponsor ID
- 109HV108 / 109HV108
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Oct 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.
This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.
Detailed description
The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.
The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Chinese Subjects - Dose 1 BG00012 | Experimental | Drug: BG00012 Dose 1 |
| Chinese Subjects - Dose 2 BG00012 | Experimental | Drug: BG00012 Dose 2 |
| Japanese Subjects - Dose 1 BG00012 | Experimental | Drug: BG00012 Dose 1 |
| Japanese Subjects - Dose 2 BG00012 | Experimental | Drug: BG00012 Dose 2 |
| Caucasian Subjects - Dose 1 BG00012 | Experimental | Drug: BG00012 Dose 1 |
| Caucasian Subjects - Dose 2 BG00012 | Experimental | Drug: BG00012 Dose 2 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Must give written informed consent and any authorizations required by local law
- 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.
Key exclusion criteria (6 listed)
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
- 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 reactions
- Known history of or positive test result for Human Immunodeficiency Virus (HIV)
- Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
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 |
|---|---|---|
| BG00012 Dose 1 | Drug | Caucasian Subjects - Dose 1 BG00012, Chinese Subjects - Dose 1 BG00012, Japanese Subjects - Dose 1 BG00012 |
| BG00012 Dose 2 | Drug | Caucasian Subjects - Dose 2 BG00012, Chinese Subjects - Dose 2 BG00012, Japanese Subjects - Dose 2 BG00012 |
Primary outcome
AUC of BG00012
Time frame: First dose to 24 hours
Cmax of BG00012
Time frame: First dose to 24 hours
2 secondary outcomes
Number of Adverse Events, as a measure of safety and tolerability
Time frame: Subjects will be followed for the duration of the study, an expected 20 days
Number of Serious Adverse Events, as a measure of safety and tolerability
Time frame: Subjects will be followed for the duration of the study, an expected 20 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 16 Sep 2013.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG00012 Dose 1 and BG00012 Dose 2 in people with Healthy, run by Biogen at 2 sites in 2 countries.
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 6 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 Sep 2013. 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 Australia, China. 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?
AUC of BG00012 (time frame: First dose to 24 hours). 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 16 Sep 2013.