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
  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: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   50 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 27, 2009
Last Updated: May 20, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Healthy Volunteers
ADME

Additional relevant MeSH terms:
Saracatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014