ClinicalTrials.gg
Sign In
CompletedNCT00531193Updated Jul 30, 2008

Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers

A Phase 1 interventional study of BIIB014 and [11C]SCH442416 in Healthy, sponsored by Biogen. Completed at 1 site in United Kingdom. Open to male participants aged 25 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-30.

Sponsored by Biogen · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
25 Years to 55 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Healthy

Keywords

  • Healthy male volunteers
03

In context

Lead sponsor

Biogen is the lead sponsor of 511 studies on the registry; 24 are open to participants now.

Of its 100 completed or terminated interventional studies of FDA-regulated products, 49 (49%) have results posted.

Browse Biogen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Other
    1

    Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results)

    Drug: BIIB014 · Other: [11C]SCH442416

Interventions

  • DrugBIIB014

    oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocol

  • Other[11C]SCH442416

    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.

06

What researchers measure

Primary outcomes

  1. PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum.

    Time frame: pre-dose and 24h following last dose

Secondary outcomes

  1. Concentrations of BIIB014 and its N-acetyl metabolite will be measured in blood plasma

    Time frame: up to 24h following last dose

07

Study locations

1 site
  • Research Site
    London, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Apr 2008 and a completion of Apr 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2007
First posted
Sep 18, 2007
Start
Sep 2007
Primary completionActual
Apr 2008
CompletionActual
Apr 2008
Last update
Jul 30, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00531193
Lead sponsor
Biogen
First posted
Sep 18, 2007
Start date
Sep 2007
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Jul 30, 2008

Study contacts

Biogen Idec
study director · Cambridge, MA USA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Vipadenant

Other studies from this sponsor

Biogen →

Start the discussion