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

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00853983

First received: February 27, 2009

Last updated: May 20, 2009

Last verified: May 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 27, 2009

Last Updated Date

May 20, 2009

Start Date ^ICMJE

March 2009

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530 [ Time Frame: Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00853983 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG [ Time Frame: From time of consent to last visit ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: [14C] AZD0530

Solution, Oral, once

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00853983

Other Study ID Numbers ^ICMJE

D8180C00013

Has Data Monitoring Committee

Responsible Party

Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Raj Chetty, MD	AstraZeneca, Clinical Pharamcology Unit, Alderley Park
Study Director:	Mary Stuart, MD	AstraZeneca, Parklands, Alderley Park

Information Provided By

AstraZeneca

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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