Using PET Scans to Study Brain Receptor Occupancy of BIIB014 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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|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|
- PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum. [ Time Frame: pre-dose and 24h following last dose ] [ Designated as safety issue: No ]
- Concentrations of BIIB014 and its N-acetyl metabolite will be measured in blood plasma [ Time Frame: up to 24h following last dose ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results)
oral administration of BIIB014, given once daily for 8 to 12 consecutive days, at various doses as specified in protocolOther: [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.
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.