Positron Emission Tomography (PET) Study

NCT ID: NCT00886067

Last Updated: 2009-09-10

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-08-31

Brief Summary

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The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.

Detailed Description

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Conditions

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Healthy

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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2-[18F]-F-A85380

Single microdose

Group Type EXPERIMENTAL

2-[18F]-F-A85380

Intervention Type RADIATION

iv, single dose

AZD1446

Single oral administration

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Solution, oral, single dose

Interventions

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AZD1446

Solution, oral, single dose

Intervention Type DRUG

2-[18F]-F-A85380

iv, single dose

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Physically healthy volunteers
* Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2

Exclusion Criteria

* History of any clinically significant disease or disorder
* History of severe allergy/hypersensitivity reactions
* Participation in a PET examination as part of a scientific study during the past twelve months
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Björn Paulsson, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca Södertälje

Ingemar, Bylesjö, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca CPU Huddinge

Locations

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Research Site

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EudraCT No. 2008-008390-55

Identifier Type: -

Identifier Source: secondary_id

D1950C00004

Identifier Type: -

Identifier Source: org_study_id

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