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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00853983 |
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Date of registration:
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27/02/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers |
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Date of first enrolment:
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March 2009 |
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Target sample size:
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6 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00853983 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Raj Chetty, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca, Clinical Pharamcology Unit, Alderley Park |
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Name:
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Mary Stuart, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca, Parklands, Alderley Park |
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Key inclusion & exclusion criteria
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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
Age minimum:
50 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: [14C] AZD0530
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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Secondary ID(s)
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D8180C00013
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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