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

NCT00531193 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2008-07-30

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

DRUG

BIIB014

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.

Sponsors & Collaborators

Principal Investigators

  • Biogen Idec · Cambridge, MA USA

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00531193 on ClinicalTrials.gov