Safety, Tolerability, PK AZD9164 SAD and MAD in Japanese healthy vols

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 after Administration of Single and Multiple Ascending Doses for 13 days in Healthy Male and Female Japanese Subjects

• IRAS ID

  33276

• Contact name

  Ulrike Lorch

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2009-015560-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study aims to assess the safety and tolerability of AZD9164 in healthy male and female Japanese volunteers. It will also investigate how the body handles this Investigational Medicinal Product (IMP). This study has been designed and sponsored by AstraZeneca (AZ) and will be conducted by Richmond Pharmacology Limited (RPL).This study will involved up to 27 healthy Japanese volunteers aged 20 to 45 years. Since there are possible differences in how the IMP is handled by the body in different ethnic groups, the IMP must be assessed in Japanese volunteers before it can be given to Japanese patients. AZD9164 is a new drug being developed for the treatment of chronic obstructive pulmonary disease (COPD), which refers to diseases of the lungs where the airways become narrowed and/or parts of the lung are irreversibly damaged. COPD is one of the leading causes of death in the world. AZD9164 is not available by prescription or over the counter medication but is under research in clinical trials. AZD9164 will be given through a Turbuhaler which is a sort of device used to administer drugs by inhalation (like an inhaler for asthma medication).This study will be conducted at one site in the UK and 27 healthy Japanese volunteers will participate. The clinical part of the study will take place over approximately 4 months (to complete all subjects). Volunteers will be given the IMP on Day 1 and Days 4 to 15 (inclusive). They will leave the unit on Day 17 and return for a safety follow up visit 7-13 days after the last dose. In total, the length of the study for an individual is approximately 8 weeks.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  09/IEC04/7

• Date of REC Opinion

  22 Dec 2009

• REC opinion

  Further Information Favourable Opinion