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

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ClinicalTrials.gov Identifier: NCT00853983
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 21, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: [14C] AZD0530 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : March 2009
Study Completion Date : April 2009

Intervention Details:
    Drug: [14C] AZD0530
    Solution, Oral, once


Primary Outcome Measures :
  1. 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 :
  1. 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 ]


Information from the National Library of Medicine

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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

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

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 Posted: March 2, 2009    Key Record Dates
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