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To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

NCT ID: NCT00689247

Last Updated: 2010-12-03

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.

Detailed Description

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Conditions

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Healthy

Keywords

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AZD1305 ADME pharmacokinetic Absorption distribution metabolism excretion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

AZD1305 given as oral solution

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

oral solution, single dose

B

AZD1305 given as iv infusion

Group Type EXPERIMENTAL

AZD1305

Intervention Type DRUG

iv infusion, single dose

Interventions

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AZD1305

oral solution, single dose

Intervention Type DRUG

AZD1305

iv infusion, single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion Criteria

* Potassium outside normal reference values
* ECG findings outside normal range
Minimum Eligible Age

35 Years

Maximum Eligible Age

55 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

Principal Investigators

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Helen Lunde, MD

Role: STUDY_DIRECTOR

AstraZeneca R&D, Mölndal, Sweden

Raj Chetty, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca CPU Alderley Park, United Kingdom

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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2007-007784-25 (EudraCT No)

Identifier Type: -

Identifier Source: secondary_id

D3190C00008

Identifier Type: -

Identifier Source: org_study_id