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Study of Uptake, Break Down and Elimination of an Investigational Drug in Healthy Volunteers

NCT ID: NCT00777361

Last Updated: 2010-11-18

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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-10-31

Brief Summary

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This study is being performed in order to learn more about a new drug (possible as treatment for people with Alzheimer's Disease and other conditions with cognitive dysfunction (memory and attention problems)) and how it is handled by the body by giving the drug to healthy volunteers with different genotypes.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Mass balance AZD3480, Pharmacokinetics, Healthy volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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AZD3480 iv

Single iv infusion AZD3480

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

Iv single dose, 4-hour infusion of 25 mg

Oral [14C] AZD3480

Single oral dose \[14C\]AZD3480

Group Type EXPERIMENTAL

AZD3480

Intervention Type DRUG

Oral solution single dose of 50 mg

Interventions

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AZD3480

Iv single dose, 4-hour infusion of 25 mg

Intervention Type DRUG

AZD3480

Oral solution single dose of 50 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Physically healthy volunteers
* Participation in a previous study for genotyping for identification to be extensive, intermediate or poor metaboliser (CYP2D6 enzyme)

Exclusion Criteria

* History of clinically significant diseases or illness.
* Ues of any prescribed or non-prescribed medications from 2 weeks prior to first treatment day except for paracetamol and OTC adrenergic nasal spray.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 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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Björn Paulsson, MD, PhD

Role: STUDY_DIRECTOR

AstraZeneca Södertälje, Sweden

Tim Mant, Prof

Role: PRINCIPAL_INVESTIGATOR

Quintiles Drug Research Unit @ Guy´s Hospital

Locations

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Research site

Macclesfield, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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EudraCT No.: 2007-005903-16

Identifier Type: -

Identifier Source: secondary_id

D3690C00017

Identifier Type: -

Identifier Source: org_study_id