Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers (ADME)
November 17, 2010 updated by: AstraZeneca
An Open, Single-Dose, Single-Centre, Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C]AZD1981 in Healthy Male Volunteers
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C]AZD1981
Study Overview
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 1
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
50 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study specific procedure
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg
Exclusion Criteria:
- Exposed to radiation levels above background of >5 mSv in the last year, >10 mSv over the last 5 years or a cumulative total of >1 mSv per year of life
- History or presence of any clinically significant disease or disorder in the opinion of the investigator
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
|
Oral tablet, 250 mg, single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pharmacokinetic variables and Radioactivity
Time Frame: Frequent sampling occasions during study days
|
Frequent sampling occasions during study days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)
Time Frame: Frequent sampling occasions during study days
|
Frequent sampling occasions during study days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eva S Pettersson, AstraZeneca R&D, Lund, Sweden
- Principal Investigator: Tim Mant, Professor, Quintiles Drug Research Unit at Guy´s Hospital, London, United Kingdom
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
February 1, 2010
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
January 26, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (Estimate)
January 28, 2010
Study Record Updates
Last Update Posted (Estimate)
November 18, 2010
Last Update Submitted That Met QC Criteria
November 17, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D9830C00006
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.