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Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects

NCT ID: NCT01007929

Last Updated: 2009-11-20

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

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-11-30

Brief Summary

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The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of \[14C\] AZD1236 in healthy male subjects.

Detailed Description

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Conditions

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Healthy

Keywords

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ADME safety oral solution

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

14C-AZD1236

Group Type EXPERIMENTAL

14C-AZD1236

Intervention Type DRUG

Oral solution 1mg/mL

Interventions

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14C-AZD1236

Oral solution 1mg/mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Non-smokers

Exclusion Criteria

* Subjects who are exposed to radiation exposure as part of their occupation
* Subjects exposed to radiation levels above background of \>5 mSv in last year, \>10 mSv over last 5 years or a cumulative total of \> 1 mSv per year of life
* A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc
Minimum Eligible Age

50 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

Principal Investigators

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AstraZeneca CPU Medical Director

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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D4260C00010

Identifier Type: -

Identifier Source: org_study_id