Mass Balance and Metabolic Profiling of [14C]AZD5672 in Healthy Male Volunteers

NCT ID: NCT00711074

Last Updated: 2009-04-09

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-07-31

Brief Summary

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The purpose of this study is to determine how the body breaks down and excretes the investigational drug, AZD5672.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

AZD5672

Intervention Type DRUG

single dose 200mg aqueous solution

Interventions

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AZD5672

single dose 200mg aqueous solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Body Mass index (BMI) 18-30 kg/m2, inclusive.
* Clinically normal findings in physical examination, ECG, vital signs, clinical chemistry, haematology \& urinalysis, as judged by the investigator

Exclusion Criteria

* Healthy volunteers who have been exposed to radiation levels above background (eg through X-ray examination) of \>5 mSv in the last year, \>10 mSv over the last 5 years or a cumulative total of \>1 mSv per year of life
* Clinically significant illness within the 2 weeks prior to dosing, as judged by the investigator
* Use of prescribed medication (including St. John's Wort) during the 3 weeks prior to dosing or use of over the counter drugs (including herbals, vitamins and minerals) during 1 week prior to dosing (other than occasional paracetamol use)
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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Mark Layton

Role: STUDY_DIRECTOR

AstraZeneca

Raj Chetty

Role: PRINCIPAL_INVESTIGATOR

AstraZeneca

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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2008-001528-30 (EUdract No)

Identifier Type: -

Identifier Source: secondary_id

D1710C00010

Identifier Type: -

Identifier Source: org_study_id

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