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

NCT00531193 | Completed Phase 1

• 2 other identifiers: 204HV101EUDRACT 2007-001575-10
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy male volunteers

Outcome Measures

Primary Outcomes (1)

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

  pre-dose and 24h following last dose

Secondary Outcomes (1)

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

  up to 24h following last dose

Study Arms (1)

1

OTHER

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

Drug: BIIB014; Other: [11C]SCH442416

Interventions

BIIB014 DRUG

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

1

[11C]SCH442416 OTHER

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.

1

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine

Study Officials

• Biogen Idec

  Cambridge, MA USA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 17, 2007
• First Posted: September 18, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

GB (1)