To investigate the tolerability, PK and PD of AMG 761

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 761 in Healthy Subjects and Subjects with Asthma.

• IRAS ID

  12030

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2008-005300-48

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  The drug being tested in this study is AMG 761. It is being developed for the treatment of asthma.This study objective is to investigate the tolerability, safety and the way the body handles AMG 761 after a range of single doses in both healthy male volunteers and those with asthma.The study involves a 2 night residency in a research unit, frequent visits for blood and urine samples until at least 85 days after the dose. The study will take place at research sites in London and Manchester. The study is expected to involve a total of 48 volunteers. Depending on results up to 16 additional volunteers may be enrolled.Also in this study volunteers will have the option to provide lung tissue samples through a process called bronchoscopy to investigate how AMG 761 is affecting lung tissue cells that are thought to be important in asthma. The bronchoscopy, an optional part of the study, involves a doctor looking into the large airways (the trachea and bronchi) which are the main tubes that carry air into the lungs through a flexible telescope (a fibre-optic bronchoscope which can look around corners).The information gained in this study will help the sponsor of this study to determine whether AMG 761 is suitable for further studies in asthma.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  08/H0804/167

• Date of REC Opinion

  8 Jan 2009

• REC opinion

  Further Information Favourable Opinion