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

NCT ID: NCT00531193

Last Updated: 2008-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-04-30

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.

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.

Conditions

Healthy

Keywords

Healthy male volunteers

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

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

Group Type: OTHER

BIIB014

Intervention Type: DRUG

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

[11C]SCH442416

Intervention Type: 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.

Interventions

BIIB014

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

Intervention Type: DRUG

[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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Biogen Idec

Principal Investigators

Biogen Idec

Role: STUDY_DIRECTOR

Cambridge, MA USA

Locations

Research Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

EUDRACT 2007-001575-10

Identifier Type: -

Identifier Source: secondary_id

204HV101

Identifier Type: -

Identifier Source: org_study_id