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OpenTrials
Completed

NCT Number: NCT00689247

To Study the Absorption, Distribution, Metabolism and Excretion of AZD1305

The purpose of this study is to learn more about how AZD1305 is handled by the body, i.e the absorption, distribution, metabolism and excretion of AZD1305.

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Key information

Conditions

Healthy

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Macclesfield, Cheshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy volunteers
  • A body mass index (BMI=weight/height2) of 19 to 30 kg/m2

Exclusion criteria

  • Potassium outside normal reference values
  • ECG findings outside normal range

Treatment and study plan

AZD1305

Drug

oral solution, single dose

Primary outcomes

  1. Pharmacokinetic variables

    Time frame: During all dosing visits

Secondary outcomes

  1. Adverse events, vital signs, ECG, laboratory variables and physical examination

    Time frame: During the study

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase I, Open, Randomised, Single-Centre, Crossover Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) After Oral and Intravenous Administration of 14C-labelled and Non-labelled AZD1305 to Healthy Male Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 3, 2008
Registry last updated
Dec 3, 2010

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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