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OpenTrials
Completed

NCT Number: NCT00853983

Phase I Study to Assess Absorption, Metabolism & Excretion of a Single Oral Dose [14C]AZD0530 in Healthy Male Volunteers

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.

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Key information

Conditions

Healthy

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Alderley Park, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[14C] AZD0530

Drug

Solution, Oral, once

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Phase I Study to Assess Absorption, Metabolism and Excretion of a Single Oral Dose of [14C]AZD0530 in Healthy Male Volunteers

Important dates

Study start
2009
Study completion
2009
First posted
Mar 2, 2009
Registry last updated
May 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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