To investigate metabolism, excretion and pharmacokinetics of AZD1981

• Research type

  Research Study

• Full title

  An Open, Single-dose, Single Centre, Phase I study to Assess the Metabolism, Excretion and Pharmacokinetics of [14C] AZD1981 in Healthy Male Volunteers

• IRAS ID

  40677

• Contact name

  Tim Mant

• Sponsor organisation

  Astra Zeneca AB

• Eudract number

  2009-017478-19

• ISRCTN Number

  Not submitted

• Research summary

  The purpose of this research study is to investigate how AZD 1981 is absorbed, distributed, broken down and excreted by the body. AZD1981 is a new drug being developed as a possible treatment for patients with Asthma and Chronic Obstructive Pulmonary Disease (COPD). In this study, AZD 1981 is labelled with radioactive carbon. This would allow us to track tiny quantities of the drug, its breakdown products and to determine how long they remain in the body. By measuring the drug in faeces and urine it is possible to determine how the drug is eliminated from the body. The study will take place at Quintiles Drug Research Unit at Guy's Hospital. Four healthy male volunteers aged 50 to 65 years will be enrolled in the study. Each volunteer will attend the unit for an admission period lasting 12 days. Each subject will receive one dose of AZD1981 as a solution on Day 1. The volunteers will be discharged on day eleven after dosing.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  09/H0720/129

• Date of REC Opinion

  10 Feb 2010

• REC opinion

  Further Information Favourable Opinion