Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00853983
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Alderley Park, Cheshire, United Kingdom