Effect of ketoconazole on the pharmacokinetics of AZD5069

• Research type

  Research Study

• Full title

  An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers

• IRAS ID

  116589

• Contact name

  Leonard Siew

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2012-001520-35

• Research summary

  AZD5069 is being developed by AstraZeneca and this study is being carried out on behalf of AstraZeneca by Quintiles Drug Research Unit at Guy??s Hospital. AZD5069 is being developed as an oral treatment for inflammatory lung diseases such as severe asthma and Chronic Obstructive Pulmonary Disease (COPD). Asthma is a common disease of the lungs affecting around five million people in the UK. It affects the tubes carrying air in and out of the lungs. People with asthma have sensitive airways which become irritated in some situations for example in reaction to dust or pollen. The airways become inflamed and narrow and sometimes produce more mucus than usual. This makes it difficult to breathe AZD5069 blocks the activity of a protein that is responsible for the movement of some white blood cells called neutrophils from the bone marrow into the blood and from the blood into organs such as the lungs. White blood cells are needed to fight infection but if there are too many of them they can cause damage to the organs. We hope that reducing their movement into the lungs will reduce the amount of inflammation in the lungs in severe asthma and COPD. We are conducting this study to determine whether a medicine called ketoconazole (a drug used to treat fungal infections, which is known to affect the way some drugs are handled in the body) affects the way AZD5069 is handled. This study will measure amount of AZD5069 in the blood over time. We will whether the amount of AZD5069 is different when it is given with and without ketoconazole. We will also see whether giving AZD5069 with ketoconazole makes a difference to the side effects. Approximately 15 healthy male volunteers aged 18-50 years old will be involved in this study.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/1533

• Date of REC Opinion

  13 Nov 2012

• REC opinion

  Favourable Opinion