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

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biogen
• Treatments: 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine; Adenosine; SCH 442416

Criteria

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:

• 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.