Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280

NCT ID: NCT00681746

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Anxiety

Keywords

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Anxiety GABA receptors Positron Emission Tomography PET phase I

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD6280

Intervention Type DRUG

Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.

(11C) flumazenil

Intervention Type DRUG

Single dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)

Interventions

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AZD6280

Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.

Intervention Type DRUG

(11C) flumazenil

Single dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Bo Fransson

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, Stockholm, Sweden

Eva Taavo

Role: STUDY_DIRECTOR

AstraZeneca R&D, Study Delivery, Clinical Development, Södertälje, Sweden

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Jucaite 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.

Reference Type DERIVED
PMID: 28013354 (View on PubMed)

Other Identifiers

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EudractCT 2007-006683-29

Identifier Type: -

Identifier Source: secondary_id

D0850C00011

Identifier Type: -

Identifier Source: org_study_id