AnxietyPhase 1PETNCT00681720
Positron Emission Tomography (PET) Study With (11C)Flumazenil to Determine Central GABAA Receptor Occupancy of AZD7325
A Phase 1 study testing AZD7325 and Radioligand (11C) flumazenil in people with Anxiety, run by AstraZeneca at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- AZD7325 and Radioligand (11C) flumazenil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2008to Jul 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
- Clinically normal physical findings, medical history and laboratory values.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Anxiety
- Being tested
- AZD7325, Radioligand (11C) flumazenil
- Keywords
- Anxiety, GABA receptors, Positron Emission Tomography, PET, phase I
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: AZD7325; Drug: Radioligand (11C) flumazenil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positron emission tomography using the radioligand (11C)flumazenil
Measured: 4 times per subject
Secondary outcomes (2)
To assess safety of AZD7325 by assessment of adverse events, vital signs, ECGs, physical examination, psychometric tests and laboratory variables.
Measured: 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
Measured: 3 times per subject. Up to 48 hours each time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bo Fransson, Principal investigator, AstraZeneca Clinical Pharmacology Unit, Stockholm, SwedenEva Taavo, Study director, AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681720
- Sponsor's protocol ID
- D1140C00007
- Other IDs
- EudractCT 2007-005436-86
- Acronym
- PET
- Status last verified
- Aug 2008
- First submitted
- 19 May 2008
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Cselenyi Z, Jucaite A, Farde L. EXPRESS: GABAA receptor alpha subunit distribution is congruent with functional anatomical areas in the human cortex. J Cereb Blood Flow Metab. 2026 Sep 27:271678X261494804. doi: 10.1177/0271678X261494804. Online ahead of print.
PubMed 42802645Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.
PubMed 28013354
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00681720
- Acronym / sponsor ID
- PET / D1140C00007
- Conditions
- Anxiety
- Keywords
- Anxiety, GABA receptors, Positron Emission Tomography, PET, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD7325, Drug: Radioligand (11C) flumazenil |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) of 18-30 kg/m2 and weight of 60-100 kg
- Clinically normal physical findings, medical history and laboratory values.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7325Single dose of oral solution or capsule. 3 times per subject. | Drug | 1 |
| Radioligand (11C) flumazenilSingle dose of i.v solution. 4 times per subject. (3 times together with AZD7325) | Drug | 1 |
Primary outcome
Positron emission tomography using the radioligand (11C)flumazenil
Time frame: 4 times per subject
2 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2008.
- Derived from this study: PubMed 42802645Cselenyi Z, Jucaite A, Farde L. EXPRESS: GABAA receptor alpha subunit distribution is congruent with functional anatomical areas in the human cortex. J Cereb Blood Flow Metab. 2026 Sep 27:271678X261494804. doi: 10.1177/0271678X261494804. Online ahead of print.
- Derived from this study: PubMed 28013354Jucaite A, Cselenyi Z, Lappalainen J, McCarthy DJ, Lee CM, Nyberg S, Varnas K, Stenkrona P, Halldin C, Cross A, Farde L. GABAA receptor occupancy by subtype selective GABAAalpha2,3 modulators: PET studies in humans. Psychopharmacology (Berl). 2017 Feb;234(4):707-716. doi: 10.1007/s00213-016-4506-4. Epub 2016 Dec 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Fransson principal investigator
AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden
Eva Taavo study director
AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7325 and Radioligand (11C) flumazenil in people with Anxiety, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positron emission tomography using the radioligand (11C)flumazenil (time frame: 4 times per subject). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681720, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.