Safety, tolerability, PK, PD, AZD5069 SAD/MAD in Japanese healthy vols

• Research type

  Research Study

• Full title

  A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD5069 in Healthy Japanese Subjects After Single and Multiple Ascending Doses

• IRAS ID

  43639

• Contact name

  Ulrike Lorch

• Sponsor organisation

  AstraZeneca UK Ltd

• Eudract number

  2009-018185-35

• ISRCTN Number

  requested

• Research summary

  This study aims to assess the safety and tolerability of AZD5069 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 involve up to 27 healthy Japanese volunteers aged 20 to 65 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. AZD5069 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. AZD5069 is not available by prescription or over the counter medication but is under research in clinical trials. AZD5069 will be given to the volunteer by mouth, as a liquid. This study will be conducted at one site in the UK and 27 healthy Japanese volunteers will participate (if necessary, up to 16 more volunteers may be included). Volunteers will be given the IMP on Days 1 & 11 (morning only) and Days 4-10 (morning & evening). They will leave the unit on Day 13 and return for short outpatient visits on Days 14 & 15. They will return for a safety follow up visit 7-10 days after the last dose. Each volunteer will participate for approximately 7 weeks.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/15

• Date of REC Opinion

  3 Mar 2010

• REC opinion

  Favourable Opinion