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Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects

NCT ID: NCT00686413

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-08-31

Brief Summary

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The study is being performed in order to learn more about AZD3480 (potential as treatment for patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as to investigate the period of time for this binding.

Detailed Description

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Conditions

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Healthy

Keywords

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PET AZD3480 PET examination

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

single dose, oral

2

Group Type EXPERIMENTAL

2-[18F]-F-A85380

Intervention Type RADIATION

Single dose, IV

Interventions

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AZD3480

single dose, oral

Intervention Type DRUG

2-[18F]-F-A85380

Single dose, IV

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Physically Healthy volunteers
* Genotyped with regard to CYP2D6
* Normal MRI scan at Visit 2

Exclusion Criteria

* Known or suspected drug or alcohol abuse or positive drugs of abuse screen as judged by the investigator.
* Participation in a PET examination as part of a scientific study during the past twelve months.
* Prescribed or non-prescribed from two weeks prior to the first PET examination. Occasional paracetamol and nasal spray for congestion will be allowed as medication.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 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 R&D Södertälje

Principal Investigators

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Hans-Göran, Hårdemark, MD, PhD

Role: STUDY_DIRECTOR

Clinical Neuroscience TA AstraZeneca R&D Södertälje, Sweden

Bo Fransson, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca Clinical Pharmacology Unit, C2-84, Karolinska University Hospital Huddinge, Stockholm, Sweden

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. 2007-004852-35

Identifier Type: -

Identifier Source: secondary_id

D3690C00018

Identifier Type: -

Identifier Source: org_study_id