Open-Label Absorption, Distribution, Metabolism, Excretion (ADME) and Pharmacokinetics (PK) Following a Single Oral Dose of AZD1236 in Healthy Male Subjects

November 19, 2009 updated by: AstraZeneca

An Open-Label. Phase I Study to Assess the Excretion of Radioactivity, Metabolic Profiles and Pharmacokinetics Following a Single Oral Dose of 60 mg of [14C] AZD1236 in Healthy Male Subjects

The purpose of this study is to characterise the metabolism, excretion and pharmacokinetics of a single oral dose of [14C] AZD1236 in healthy male subjects.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Cheshire
      • Macclesfield, Cheshire, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy volunteers
  • Non-smokers

Exclusion Criteria:

  • Subjects who are exposed to radiation exposure as part of their occupation
  • Subjects exposed to radiation levels above background of >5 mSv in last year, >10 mSv over last 5 years or a cumulative total of > 1 mSv per year of life
  • A history or presence of conditions known to interfere with the absorption, distribution, metabolism or excretion for drugs eg. haematological, gastrointestinal, hepatic or renal disease etc

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
14C-AZD1236
Drug: 14C-AZD1236
Oral solution 1mg/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic profile. Concentration of AZD1236 in plasma
Time Frame: Before and after dosing
Before and after dosing
Total Radioactivity
Time Frame: Before and after dosing
Before and after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events, clinical chemistry, haematology, urinalysis, pulse and blood pressure, ECG and physical examination
Time Frame: Before and after dosing
Before and after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: AstraZeneca CPU Medical Director, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Study Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

October 29, 2009

First Submitted That Met QC Criteria

November 4, 2009

First Posted (Estimate)

November 5, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2009

Last Update Submitted That Met QC Criteria

November 19, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D4260C00010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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