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

Study Timeline

• Study First Submitted: 2009-02-27
• Study First Submitted QC: 2009-02-27
• Study Start: 2009-03
• Study First Posted: 2009-03-02
• Study Completion: 2009-04
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-20
• Last Update Posted: 2009-05-21

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