Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 27, 2009
Last updated: May 20, 2009
Last verified: May 2009

February 27, 2009
May 20, 2009
March 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00853983 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers
An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers
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.
Not Provided
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Drug: [14C] AZD0530
Solution, Oral, once
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2009
Not Provided

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
50 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals
Not Provided
Principal Investigator: Raj Chetty, MD AstraZeneca, Clinical Pharamcology Unit, Alderley Park
Study Director: Mary Stuart, MD AstraZeneca, Parklands, Alderley Park
May 2009

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