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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:
ClinicalTrials.gov Identifier:
NCT00853983
First Posted: March 2, 2009
Last Update Posted: May 21, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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.

Condition Intervention Phase
Healthy Drug: [14C] AZD0530 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: March 2009
Study Completion Date: April 2009
Intervention Details:
    Drug: [14C] AZD0530
    Solution, Oral, once
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853983


Locations
United Kingdom
Research Site
Alderley Park, Cheshire, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Raj Chetty, MD AstraZeneca, Clinical Pharamcology Unit, Alderley Park
Study Director: Mary Stuart, MD AstraZeneca, Parklands, Alderley Park
  More Information

Responsible Party: Mary Stuart, MD, Medical Science Director, Emerging Product Team 1, Oncology, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00853983     History of Changes
Other Study ID Numbers: D8180C00013
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: May 21, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
Healthy Volunteers
ADME

Additional relevant MeSH terms:
Saracatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action