To investigate bioavailability of AZD 5423 orally, IV and inhaled.

• Research type

  Research Study

• Full title

  An Open, Partly Randomised, Four-way Cross-over Study in Healthy Subjects and in Patients with Mild Allergic Asthma to Investigate the Bioavailability and Basic Pharmacokinetics of a Single Dose of AZD5423 when Administered Intravenously, Orally, Inhaled via SPIRA Nebuliser or Inhaled via I-neb® AAD Systems

• IRAS ID

  74728

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2010-023051-28

• Research summary

  ReThe drug being tested in this trial is AZD5423. It is being developed as a possible treatment for patients with asthma and chronic obstructive pulmonary disease (COPD ??i.e. chronic bronchitis and emphysema). This will be the third study where AZD5423 is to be given to man. However it will be the first study where AZD5423 is given via a liquid to swallow and via an infusion directly into a vein. The main purpose of this study is to determine the amount of AZD5423 that enters the volunteer's body when given by mouth, via a vein and via the lungs on different occasions. Levels of AZD5423 will be measured in the blood. We will also compare two different devices (nebulizers) that deliver the drug via the lungs. The study will be carried out at Quintiles's Drug Research Unit and will include 6 healthy male subjects and 6 male patients with mild allergic asthma, aged 18 to 45 years (inclusive). The duration of the study will be approximately 11 weeks and will consist of 6 visits. In total, 4 single doses will be administered on 4 separate occasions. There will be a wash-out period of at least 2 weeks between the different treatments. Volunteers will receive the drug once into the vein, twice inhaled and once orally. Each admission period will consist of 4 study days in the unit (Day ??1, Day 1 to Day 3). Volunteers will return as outpatients on Day 4 and 5 for blood samples. The information gained in this study will help the sponsor of this study to determine the amount of AZD5423 that is absorbed into the body when given by different dosing methods.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/0039

• Date of REC Opinion

  7 Apr 2011

• REC opinion

  Further Information Favourable Opinion