Multiple SclerosisPhase 1NCT02521545
Single-Dose Study of a New Formulation of BIIB061
A Phase 1 study testing BIIB061 in people with Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- BIIB061
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Aug 2015
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females.
- All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
- Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
- Body mass index of 18.0 to 30.0 kg/m2, inclusive.
Who cannot join
- History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- Prior exposure to BIIB061.
- History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
- Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
- Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
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- Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
- Blood donation within 30 days prior to the study
- Surgery within 3 months prior to the study
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
- Conditions
- Multiple Sclerosis
- Being tested
- BIIB061
- Keywords
- Oral Remyelination
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB061Drug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| BIIB061 | Experimental | Single oral dose of 30 mg BIIB061 of the new formulation Receives: Drug: BIIB061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Measured: Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Measured: Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)
Measured: Day 1-4, 6, 10, 14, 21
Secondary outcomes (6)
PK parameter - Time to reach maximum observed concentration (Tmax)
Measured: Day 1-4, 6, 10, 14, 21
PK parameter - half-life (t1/2)
Measured: Day 1-4, 6, 10, 14, 21
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 21 days
Assessment of changes from baseline in Clinical laboratory parameters
Measured: Up to 21 days
Assessment of clinically relevant abnormalities in Vital signs
Measured: Up to 21 days
Assessment of physical examinations
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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
- NCT02521545
- Sponsor's protocol ID
- 231HV103
- Status last verified
- Sep 2015
- First submitted
- 16 Jul 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
- ClinicalTrials.gov ID
- NCT02521545
- Acronym / sponsor ID
- 231HV103
- Conditions
- Multiple Sclerosis
- Keywords
- Oral Remyelination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Aug 2015 (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 the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIIB061 | Experimental | Drug: BIIB061Single oral dose of 30 mg BIIB061 of the new formulation |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females.
- All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
- Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
- Body mass index of 18.0 to 30.0 kg/m2, inclusive.
Key exclusion criteria (10 listed)
- History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- Prior exposure to BIIB061.
- History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
- Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the 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 |
|---|---|---|
| BIIB061Capsule | Drug | BIIB061 |
Primary outcome
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)
Time frame: Day 1-4, 6, 10, 14, 21
6 secondary outcomes
PK parameter - Time to reach maximum observed concentration (Tmax)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - half-life (t1/2)
Time frame: Day 1-4, 6, 10, 14, 21
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 21 days
Assessment of changes from baseline in Clinical laboratory parameters
Time frame: Up to 21 days
Assessment of clinically relevant abnormalities in Vital signs
Time frame: Up to 21 days
Assessment of physical examinations
Time frame: Up to 21 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 7 Sep 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 BIIB061 in people with Multiple Sclerosis, 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 4 inclusion and 10 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 7 Sep 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 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 parameter - area under the concentration-time curve from time 0 to infinity (AUCinf) (time frame: Day 1-4, 6, 10, 14, 21). The study lists 3 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 7 Sep 2015.