NCT00681746CompletedPhase 1
An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280 After Oral Administration to Healthy Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Positron emission tomography using the radioligand (11C) flumazenil
Study Overview
Brief Summary
The study is carried out in order to determine the relationship between the dose of AZD6280 and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to GABAA receptors
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
- •Clinically normal physical findings, medical history and laboratory values.
Exclusion Criteria
- •Clinically significant illness or clinical relevant trauma within 2 weeks before the study start.
- •History of clinically significant heart arrythmias or heart disease/problems.
- •Previous participation in a PET study within the past 12 months. Suffer from claustrophobia and would be unable to undergo MRI (magnetic resonance imaging) or PET scanning.
Arms & Interventions
1
Experimental
Intervention: AZD6280 (Drug)
1
Experimental
Intervention: (11C) flumazenil (Drug)
Outcomes
Primary Outcomes
Positron emission tomography using the radioligand (11C) flumazenil
Time Frame: 4 times per subject
Secondary Outcomes
- To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, psychometric tests and laboratory variables.(6 visits with tests for the 2 subjects in the first group (Panel 1). 4 visits with tests for the 6 remaining subjects. Some tests will be done several times per visit. All tests will not be done at every visit.)
- Investigate the pharmacokinetics of AZD6280 following single doses of AZD6280 by assessment of drug concentration in plasma.(3 times for the 2 subjects in the first group (Panel 1). Once for the 6 remaining subjects. Up to 48 hours at each time.)
Investigators
Study Sites (1)
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