Using PET Scans to Study Brain Receptor Occupancy of BIIB014 in Healthy Male Volunteers
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| ClinicalTrials.gov Identifier: NCT00531193 |
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Recruitment Status :
Completed
First Posted : September 18, 2007
Last Update Posted : July 30, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy | Drug: BIIB014 Other: [11C]SCH442416 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 32 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| 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 |
| Study Start Date : | September 2007 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
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1
Various protocol-specified doses of BIIB014 will be used (doses to be determined by PET scan results)
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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. |
- PET scanning with [11C]SCH442416 of the putamen, caudate, nucleus accumbens, thalamus, and cerebellum. [ Time Frame: pre-dose and 24h following last dose ]
- Concentrations of BIIB014 and its N-acetyl metabolite will be measured in blood plasma [ Time Frame: up to 24h following last dose ]
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| Ages Eligible for Study: | 25 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531193
| United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Study Director: | Biogen Idec | Cambridge, MA USA |
| Responsible Party: | Biogen Idec MD, Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT00531193 History of Changes |
| Other Study ID Numbers: |
204HV101 EUDRACT 2007-001575-10 |
| First Posted: | September 18, 2007 Key Record Dates |
| Last Update Posted: | July 30, 2008 |
| Last Verified: | July 2008 |
Keywords provided by Biogen:
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Healthy male volunteers |
Additional relevant MeSH terms:
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Adenosine 3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Arrhythmia Agents Vasodilator Agents |
Purinergic P1 Receptor Agonists Purinergic Agonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adenosine A2 Receptor Antagonists Purinergic P1 Receptor Antagonists Purinergic Antagonists |