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

An Open Label Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325 After Oral Administration to Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00681720

Acronym

PET

Enrollment

Registered

2008-05-21

Start date

2008-02-29

Completion date

2008-07-31

Last updated

2008-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

Anxiety, GABA receptors, Positron Emission Tomography, PET, phase I

Brief summary

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.

Interventions

DRUGAZD7325

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

DRUGRadioligand (11C) flumazenil

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

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. * 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.

Design outcomes

Primary

Measure	Time frame
Positron emission tomography using the radioligand (11C)flumazenil	4 times per subject

Secondary

Measure	Time frame
To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.	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	3 times per subject. Up to 48 hours each time.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026