Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers

NCT ID: NCT00853983

Last Updated: 2009-05-21

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-04-30

Brief Summary

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The aim of this study is to show how the body absorbs, metabolises and excretes the drug \[14C\]AZD0530. As for all clinical trials, safety and tolerability of the drug will be evaluated.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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[14C] AZD0530

Solution, Oral, once

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Regular Daily Bowel movements
* Veins suitable for cannulation or repeated venepuncture

Exclusion Criteria

* Presence of any clinically significant illness
* Abnormal vital signs
* History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
Minimum Eligible Age

50 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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Raj Chetty, MD

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca, Clinical Pharamcology Unit, Alderley Park

Mary Stuart, MD

Role: STUDY_DIRECTOR

AstraZeneca, Parklands, Alderley Park

Locations

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Research Site

Alderley Park, Cheshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D8180C00013

Identifier Type: -

Identifier Source: org_study_id

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