Status:
COMPLETED
Assess Safety, Tolerability and PK of AZD3199 in Japanese
Lead Sponsor:
AstraZeneca
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to investigate the safety and tolerability of single and multiple once daily ascending doses of AZD3199 delivered as dry powder via the Turbuhaler inhaler in heal...
Eligibility Criteria
Inclusion
- Be healthy Japanese volunteers, both of the volunteer's parents, and all grandparents must be Japanese. The volunteer must have been born in Japan, have a valid Japanese passport and must not have lived outside Japan for for more than 5 years.
- BMI 18 - 27, Weight 50 - 85 kg
- Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start.
- Clinical normal physical findings
Exclusion
- Any clinically significant disease or disorder
- Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- Use of any medication (including OTC), herbal preparations, vitamins or nutritional supplements within 2 weeks prior to Visit 2, except for occasional intake of paracetamol (maximum daily dose of 4 g)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00772759
Start Date
October 1 2008
End Date
February 1 2009
Last Update
May 5 2009
Active Locations (1)
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1
Research Site
Slough, Berkshire, United Kingdom