HealthyPhase 1NCT00531193
Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers
A Phase 1 study testing BIIB014 and [11C]SCH442416 in people with Healthy, run by Biogen at 1 site in United Kingdom.
Trial summary
To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed by PET scanning using a radiolabelled tracer. Read more about this study
- Who is it for?
- Ages 25 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BIIB014 and [11C]SCH442416
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to Apr 2008
- 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 25 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18.0 and 29.0 kg/m2
- Willing to abstain from caffeine-containing products from 1 week prior to dosing until discharge from unit.
- Willing and able to practice effective contraception until 2 months following last dose of study drug.
Who cannot join
- History of severe allergic reactions or clinically significant allergies.
- History of malignancy, excluding adequately treated basal cell carcinoma.
- History of any clinically significant disease.
- History of claustrophobia or any condition incompatible with MRI/PET scanning.
- History of any exposure to ionizing radiation, with the exception of dental x-rays, within the 12 months prior to dosing.
- Serious infection within the 4 weeks prior to dosing.
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- HbA1c > 6%, positive for Hepatitis C or Hepatitis B, presence of HIV or known exposure to HIV, positive G6PD assay, or any other clinically significant abnormal laboratory parameters at Screening.
- Abnormal supine or standing blood pressure or orthostatic hypotension.
- Any prior treatment with antipsychotic medications, dopamine antagonists, or dopaminergic agonists.
- Treatment with any other investigational drug within 3 months prior to dosing.
- Treatment with any prescription medications within 4 weeks prior to dosing.
- History of drug or alcohol abuse within 1 year prior to dosing.
- Current smoker or any tobacco use within 3 months prior to dosing.
- Heavy caffeine consumption within 4 weeks prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Positron Emission Tomography Study to Assess Adenosine A2A Brain Receptor Occupancy of BIIB014 at Multiple Dose Levels in Healthy Male Volunteers
To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed by PET scanning using a radiolabelled tracer.
Read the detailed description
Subjects will be enrolled sequentially into cohorts of 2 to 4 subjects. PET scan results will determine the actual number of cohorts enrolled and the BIIB014 dose given to each subject. Since all enrolled subjects will be receiving BIIB014, this study is being listed as a 1-arm, Single Group study (actual study design is dose escalation).
Participating subjects will be required to reside in the clinical unit for 10 to 14 consecutive days. Participants will receive 1 oral dose of BIIB014 daily for 8 to 12 consecutive days. During the study, subjects will undergo 2 PET scans and 1 MRI. Frequent blood sample for pharmacokinetic assessments will also be performed.
- Conditions
- Healthy
- Being tested
- BIIB014, [11C]SCH442416
- Keywords
- Healthy male volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB014Drug
oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol
[11C]SCH442416Other
11C]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. [11C]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results) Receives: Drug: BIIB014; Other: [11C]SCH442416 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum.
Measured: pre-dose and 24h following last dose
Secondary outcomes (1)
Concentrations of BIIB014 and its N-acetyl metabolite will be measured in blood plasma
Measured: up to 24h following last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2008
- Study completionApr 2008
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Biogen Idec, Study director, Cambridge, MA USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531193
- Sponsor's protocol ID
- 204HV101
- Other IDs
- EUDRACT 2007-001575-10
- Status last verified
- Jul 2008
- First submitted
- 17 Sep 2007
- Last updated
- 30 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Positron Emission Tomography Study to Assess Adenosine A2A Brain Receptor Occupancy of BIIB014 at Multiple Dose Levels in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT00531193
- Acronym / sponsor ID
- 204HV101
- Conditions
- Healthy
- Keywords
- Healthy male volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Sep 2007 (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.
To establish the extent to which BIIB014, following 8 to 12 consecutive days of dosing at selected dose levels, occupies the brain's A2A receptors. Receptor occupancy will be assessed by PET scanning using a radiolabelled tracer.
Detailed description
Subjects will be enrolled sequentially into cohorts of 2 to 4 subjects. PET scan results will determine the actual number of cohorts enrolled and the BIIB014 dose given to each subject. Since all enrolled subjects will be receiving BIIB014, this study is being listed as a 1-arm, Single Group study (actual study design is dose escalation).
Participating subjects will be required to reside in the clinical unit for 10 to 14 consecutive days. Participants will receive 1 oral dose of BIIB014 daily for 8 to 12 consecutive days. During the study, subjects will undergo 2 PET scans and 1 MRI. Frequent blood sample for pharmacokinetic assessments will also be performed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: BIIB014, Other: [11C]SCH442416Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results) |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI between 18.0 and 29.0 kg/m2
- Willing to abstain from caffeine-containing products from 1 week prior to dosing until discharge from unit.
- Willing and able to practice effective contraception until 2 months following last dose of study drug.
Key exclusion criteria (14 listed)
- History of severe allergic reactions or clinically significant allergies.
- History of malignancy, excluding adequately treated basal cell carcinoma.
- History of any clinically significant disease.
- History of claustrophobia or any condition incompatible with MRI/PET scanning.
- History of any exposure to ionizing radiation, with the exception of dental x-rays, within the 12 months prior to dosing.
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 |
|---|---|---|
| BIIB014oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol | Drug | 1 |
| [11C]SCH44241611C]SCH442416 is a radiolabelled tracer molecule that specifically binds to adenosine A2A sites and will be used to evaluate receptor occupancy. The target activity will be 370 MBq. [11C]SCH442416 will be administered IV as a bolus injection over 30 seconds following the start of each PET scan. | Other | 1 |
Primary outcome
PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum.
Time frame: pre-dose and 24h following last dose
1 secondary outcome
Concentrations of BIIB014 and its N-acetyl metabolite will be measured in blood plasma
Time frame: up to 24h following last dose
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 30 Jul 2008.
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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 study director
Cambridge, MA USA
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 BIIB014 and [11C]SCH442416 in people with Healthy, run by Biogen at 1 site in United Kingdom.
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 14 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 30 Jul 2008. 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 Kingdom. 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?
PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum. (time frame: pre-dose and 24h following last dose). 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 30 Jul 2008; AzTrials last refreshed its copy on 6 Nov 2026.