Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers
An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Mar 2009
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedMay 21, 2009
May 1, 2009
February 27, 2009
May 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To characterise the absorption, metabolism and excretion of a single oral dose of 400mg [14C]AZD0530
Multiple PK, Urine and faeces samples taken between predose to 240 hours post dose
Secondary Outcomes (1)
To evaluate the safety profile by assessment of adverse events, physical examination, pulse, blood pressure, clinical chemistry, haematology, urinalysis & ECG
From time of consent to last visit
Interventions
Solution, Oral, once
Eligibility Criteria
You may qualify if:
- Regular Daily Bowel movements
- Veins suitable for cannulation or repeated venepuncture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Alderley Park, Cheshire, United Kingdom
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Raj Chetty, MD
AstraZeneca, Clinical Pharamcology Unit, Alderley Park
- STUDY DIRECTOR
Mary Stuart, MD
AstraZeneca, Parklands, Alderley Park
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 2, 2009
Study Start
March 1, 2009
Study Completion
April 1, 2009
Last Updated
May 21, 2009
Record last verified: 2009-05