Healthy VolunteersPhase 1NCT01632449
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.
A Phase 1 study testing Test product and Reference product in people with Healthy Volunteers, run by Biogen at 1 site in United States.
Trial summary
This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Test product and Reference product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Sep 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 and informed consent and any authorizations required by local law.
- Males and females 18 - 55 years old inclusive at time of consent.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
Who cannot join
- History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- 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.
- Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
- Current enrollment in any other drug, biologic, or device study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
Read the detailed description
This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.
- Conditions
- Healthy Volunteers
- Being tested
- Test product, Reference product
- Keywords
- bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test productDrug
Dimethyl Fumarate (BG00012)
Reference productDrug
Dimethyl Fumarate (BG00012)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Test product Receives: Drug: Test product; Drug: Reference product |
| 2 | Experimental | Reference product Receives: Drug: Test product; Drug: Reference product |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK - Area under the plasma concentration curve.
Measured: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Peak plasma concentration as a measure of PK.
Measured: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Secondary outcomes (1)
The number of AEs in participants as a measure of safety and tolerability.
Measured: Participants will be followed during the study, 4 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632449
- Sponsor's protocol ID
- 109HV109
- Status last verified
- May 2013
- First submitted
- 21 Jun 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.
- ClinicalTrials.gov ID
- NCT01632449
- Acronym / sponsor ID
- 109HV109
- Conditions
- Healthy Volunteers
- Keywords
- bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Jul 2012 (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 single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.
Detailed description
This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Test product, Drug: Reference productTest product |
| 2 | Experimental | Drug: Test product, Drug: Reference productReference product |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must give written and informed consent and any authorizations required by local law.
- Males and females 18 - 55 years old inclusive at time of consent.
- Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive
Key exclusion criteria (4 listed)
- History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
- 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.
- Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
- Current enrollment in any other drug, biologic, or device study.
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 |
|---|---|---|
| Test productDimethyl Fumarate (BG00012) | Drug | 1, 2 |
| Reference productDimethyl Fumarate (BG00012) | Drug | 1, 2 |
Primary outcome
PK - Area under the plasma concentration curve.
Time frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Peak plasma concentration as a measure of PK.
Time frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
1 secondary outcome
The number of AEs in participants as a measure of safety and tolerability.
Time frame: Participants will be followed during the study, 4 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 31 May 2013.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 Test product and Reference product in people with Healthy Volunteers, 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 3 inclusion and 4 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 31 May 2013. 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. 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 - Area under the plasma concentration curve. (time frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 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 31 May 2013.