Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers - Full Text View

Sponsored by:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00531193

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: BIIB014 Other: [11C]SCH442416	Phase I

MedlinePlus related topics: Nuclear Scans

Drug Information available for: Adenosine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Single Group Assignment
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

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	32
Study Start Date:	September 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results)	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.

Arms

Assigned Interventions

1

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

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.

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.

Eligibility

Ages Eligible for Study:	25 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00531193

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec

Cambridge, MA USA

More Information

Responsible Party:	Biogen Idec ( Biogen Idec MD )
Study ID Numbers:	204HV101, EUDRACT 2007-001575-10
Study First Received:	September 17, 2007
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00531193
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Biogen Idec:

Healthy male volunteers

Study placed in the following topic categories:

Healthy
Adenosine

ClinicalTrials.gov processed this record on January 16, 2009