Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325

AstraZeneca4 enrolled

Overview

The study is carried out in order to determine the relationship between the dose of AZD7325 and the blood concentration of AZD7325, and to investigate to which extent AZD7325 binds to the GABAA receptors.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Anxiety

Interventions

AZD7325DRUG

Single dose of oral solution or capsule. 3 times per subject.

Radioligand (11C) flumazenilDRUG

Single dose of i.v solution. 4 times per subject. (3 times together with AZD7325)

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. * Intake of another investigational drug or participation in a clinical study the past 12 weeks. * 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.

Locations (1)

Research Site

Stockholm, Sweden

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, physical examination, psychometric tests and laboratory variables.

Time frame: 6 visits with tests for the 2 subjects in the first group (Panel 1). 7 visits with tests for the 2 subjects in the second group (Panel 2). Some tests will be done several times per visit. All tests will not be done at every visit

Investigate the pharmacokinetics of AZD7325 following single doses of AZD7325 by assessment of drug concentration in plasma

Time frame: 3 times per subject. Up to 48 hours each time.

Data from ClinicalTrials.gov

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